Calamine Plus Pramoxine Hcl Aerosol, Spray
FDA Label NDC 56104-251

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America, Inc. for the product Calamine Plus Pramoxine Hcl (NDC 56104-251). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ​warnings, ​flammable:, ​when using this product, stop use and ask a doctor if, ​keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Calamine 8%
Pramoxine HCl 1%

Purpose

Skin protectant
External analgesic

Uses

temporarily relieves pain and itching associated with:

  • insect bites
  • rashes
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

​Warnings

For external use only.

​Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

​When Using This Product

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop Use And Ask A Doctor If

  • conditions worsens
  • symtomps last more than 7 days or clear up and occur again in a few days

​Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before using
  • adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily 
  • cleanse the skin with soap and water
  • let dry before use
  • children under 2 years of age: consult a doctor

​Other Information

store between 20° to 25°C (68° to 77°F)

​Inactive Ingredients

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

​Questions?

800-632-6900

Principal Display Panel

Cutter

Poison Ivy Drying & Soothing

Triple Action

Dries oozing & weeping

Soothes pain

Calms itching

Calamine 8%

Skin Protectant

Pramoxine HCl 1%

External Analgesic

NET WT 4.1 OZ (116g)

Artwork (50 066cu 050037540013 Calamine)

Artwork (50 066cu 050037540013 Calamine)

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