Calamine

Pharmacologic Category

Topical Skin Product

Dosing: Adult

Skin protectant: Topical: Apply to affected area as often as needed

Dosing: Pediatric

Skin irritation: Note: Approved ages in pediatric patients may vary among products, consult product specific labeling.

Calamine/zinc oxide products: Infants ≥6 months, Children, and Adolescents: Topical: Apply to affected area as often as needed; other calamine products are used up to 3 to 4 times daily

Calamine/pramoxine products: Children ≥2 years and Adolescents: Topical: Apply to affected area up to 3 to 4 times daily

Use: Labeled Indications

Employed primarily as an astringent, protectant, and soothing agent for conditions such as poison ivy, poison oak, poison sumac, sunburn, insect bites, or minor skin irritations

Administration: Topical

Shake well prior to use. Apply to clean, dry skin; avoid contact with eyes and mucous membranes; do not use on open wounds or burns.

Administration: Pediatric

Topical: Shake well before using. Apply to clean, dry skin; may apply using cotton or a soft cloth. Avoid contact with the eyes and mucous membranes; do not use on open wounds or burns.

Storage/Stability

Store at room temperature of 15ºC to 30ºC (59ºF to 86ºF).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat poison oak, ivy, and sumac rashes.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• A significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Contraindications

Hypersensitivity to any component of the formulation

Warnings/Precautions

Other warnings/precautions:

• Self-medication (OTC use): For external use only; avoid contact with eyes and mucous membranes. Discontinue use and contact healthcare provider if needed for >7 days or if condition worsens.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Lotion, External:

Caladryl: Calamine 8% and pramoxine hydrochloride 1% (177 mL) [contains methylparaben, polysorbate 80, propylene glycol, propylparaben]

Calagesic: Calamine 8% and pramoxine hydrochloride 1% (177 mL) [contains alcohol, usp, methylparaben, polysorbate 80, propylene glycol, propylparaben]

GoodSense Medicated Calamine: Calamine 8% and pramoxine hydrochloride 1% (177 mL) [contains alcohol, usp, methylparaben, polysorbate 80, propylene glycol, propylparaben]

Generic: 8% (177 mL, 180 mL); Calamine 8% and zinc oxide 8% (118 mL)

Suspension, External:

GoodSense Calamine: Calamine 8% and zinc oxide 8% (177 mL)

Generic Available (US)

Yes

Pricing: US

Lotion (Caladryl External)

1-8% (per mL): $0.03

Lotion (Calagesic External)

1-8% (per mL): $0.02

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Calamine Lotion

References

American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Caladryl (calamine) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; August 2013.

Calamine [prescribing information]. Union, NJ: Liberty Procurement, Inc.; August 2017.

Humco Calagesic (calamine) [prescribing information]. Texarkana, TX: HUMCO; March 2014.

Humco Calamine [prescribing information]. Texarkana, TX: HUMCO; March 2014.

Mak MF, Li W, Mahadev A. Calamine lotion to reduce skin irritation in children with cast immobilisation. J Orthop Surg (Hong Kong). 2013;21(2):221-225.[PubMed 24014789]

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

Somekh E, Dalal I, Shohat T, Ginsberg GM, Romano O. The burden of uncomplicated cases of chickenpox in Israel. J Infect. 2002;45(4):233-236.[PubMed 12423610]

Tebruegge M, Kuruvilla M, Margarson I. Does the use of calamine or antihistamine provide symptomatic relief from pruritus in children with varicella zoster infection? Arch Dis Child. 2006;91(12):1035-1036.[PubMed 17119083]

Brand Names: International

Calamine 15% Lotion (EG); Calamine Lotion (KW); Calamol (SG); Ducilamina (BR); Intracal (IN)

Last Updated 2/14/20