Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7f2c5adf-92ca-4257-b71b-f7578a481c92
Route
TOPICAL
Published
Effective Date 2013-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (80 mg) Ferric Oxide Red (10 mg) Pramoxine
Inactive Ingredients
Alcohol Camphor (natural) Hypromelloses Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-03
Description

Calamine 8% Pramoxine HCl 1%

Purpose

Skin protectant Topical analgesic

Medication Information

Purpose

Skin protectant

Topical analgesic

Description

Calamine 8% Pramoxine HCl 1%

Uses

temporarily relieves pain and itching associated with:

  • rashes due to poison ivy, poison oac or poison sumac
  • insect bites
  • minor skin irritation
  • minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Directions
  • shake well before use
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Package Label

Other Information
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

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

Structured Label Content

Uses

temporarily relieves pain and itching associated with:

  • rashes due to poison ivy, poison oac or poison sumac
  • insect bites
  • minor skin irritation
  • minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Purpose

Skin protectant

Topical analgesic

Warnings

For external use only.

Directions
  • shake well before use
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Package Label

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Active Ingredients (Active ingredients)

Calamine 8%

Pramoxine HCl 1%

Inactive Ingredients (Inactive ingredients)

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.646934 · Updated: 2026-03-14T22:53:30.775793