3a01f57a-ebc6-4724-b625-1d1ea4b85e73

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

Purpose

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

Description

Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%


Medication Information

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

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.
Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

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

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
Inactive Ingredients

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

Description

Diphenhydramine Hydrochloride 2% Zinc Acetate 0.1%

Section 51945-4

Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

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

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

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.
Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

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

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
Inactive Ingredients

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

Section 51945-4 (51945-4)

Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

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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