Calamine Plus Aerosol, Spray
FDA Label NDC 49035-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Calamine Plus (NDC 49035-030). 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 ingredients, purpose, keep out of reach of children, uses, warnings, flammable, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Calamine 8%

Pramoxine HCL 1%

Purpose

Purpose

Skin protectant

External analgesic

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Flammable

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 degrees F.

When Using This Product

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

Stop use and ask a doctor if

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

Directions

Directions

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

Other Information

Other information

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

Inactive Ingredients

Inactive ingredients

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


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