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
Purpose

Skin protectant Topical analgesic

Description

Calamine 8% Pramoxine HCl 1%

Medication Information

Warnings

For external use only.

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

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

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

Description

Calamine 8% Pramoxine HCl 1%

Package Label

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

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

Warnings

For external use only.

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

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

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

Package Label

Active Ingredients (Active ingredients)

Calamine 8%

Pramoxine HCl 1%

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