SPL v4
SPL
SPL Set ID 3a01f57a-ebc6-4724-b625-1d1ea4b85e73
Route
TOPICAL
Published
Effective Date 2024-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg) Zinc Cation (1 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Glyceryl Monostearate Glycerin Methylparaben Propylparaben Light Mineral Oil Polysorbate 60 Stearic Acid Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%

Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic Zinc Acetate 0.1%.............................Skin Protectant


Medication Information

Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

Zinc Acetate 0.1%.............................Skin Protectant

Description

Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%

Uses

Uses

  • temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Section 51945-4

Warnings

For external use only.

Due not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use:

  • on chicken pox
  • on measles

When using this productavoid contact with eyes

Stop use and ask a doctor if:

  • condition worsens or does not improve within 7 days
  • symptoms persists for more than 7 days or clear up and occur again within a few days

Directions
  • do not use more than directed
  • 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
Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Inactive Ingredients

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60, propylparaben,  purified water, stearic acid

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.


Structured Label Content

Uses

Uses

  • temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
Section 51945-4 (51945-4)

Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

Zinc Acetate 0.1%.............................Skin Protectant

Warnings

For external use only.

Due not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use:

  • on chicken pox
  • on measles

When using this productavoid contact with eyes

Stop use and ask a doctor if:

  • condition worsens or does not improve within 7 days
  • symptoms persists for more than 7 days or clear up and occur again within a few days

Directions
  • do not use more than directed
  • 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
Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Inactive Ingredients

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60, propylparaben,  purified water, stearic acid

Keep Out of Reach of Children (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

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