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Calamine lotion: Pediatric drug information

Calamine lotion: Pediatric drug information
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For additional information see "Calamine lotion: Drug information" and "Calamine lotion: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Caladryl [OTC];
  • Calagesic [OTC];
  • GoodSense Calamine [OTC];
  • GoodSense Medicated Calamine [OTC]
Therapeutic Category
  • Topical Skin Product
Dosing: Pediatric
Skin irritation

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

Dosing: Adult

(For additional information see "Calamine lotion: Drug information")

Skin irritation

Skin irritation: Topical: Apply to affected area as often as needed (zinc oxide–containing products) or up to 3 to 4 times daily (pramoxine-containing products).

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

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).

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)

Suspension, External:

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

Generic Equivalent Available: US

Yes

Pricing: US

Lotion (Caladryl External)

1-8% (per mL): $0.03

Lotion (Calagesic External)

1-8% (per mL): $0.03

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.

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.

Administration: Adult

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.

Storage/Stability

Store at controlled room temperature.

Use

Temporary relief of pain and itching associated with rashes due to poison ivy, poison oak, or poison sumac; insect bites; minor skin irritation; or minor cuts and to dry oozing and weeping of poison ivy, poison oak, and poison sumac (in combination with zinc oxide: FDA approved in ages ≥6 months and adults; in combination with pramoxine: FDA approved in ages ≥2 years and adults); has also been used for skin irritation and itching due to varicella (chicken pox) infection. Note: Approved ages in pediatric patients may vary among products, consult product specific labeling.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BR) Brazil: Calamax | Calamina;
  • (CO) Colombia: Calamyl plus | Calapic | Farmadryl;
  • (DO) Dominican Republic: Calamina;
  • (GB) United Kingdom: Once bitten;
  • (IN) India: Calaminol | Cosmine | Dermocalm | Linical | Mahalac;
  • (KE) Kenya: Caladin;
  • (KW) Kuwait: Bell's Calamine B.P.;
  • (NO) Norway: Calamin Naf;
  • (PR) Puerto Rico: Calagesic;
  • (QA) Qatar: Caladerm | Dermocal;
  • (SG) Singapore: Calamol;
  • (TH) Thailand: K.b.calo | Unif;
  • (UG) Uganda: Ago calamine | Caladin;
  • (VE) Venezuela, Bolivarian Republic of: Calamina
  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Caladryl (calamine) [prescribing information]. Bridgewater, NJ: Bausch Health Companies; January 2020.
  3. Calamine [prescribing information]. Chesterbrook, PA: AmerisourceBergen; received March 2021.
  4. Humco Calagesic (calamine) [prescribing information]. Texarkana, TX: HUMCO; received March 2021.
  5. 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]
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