Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ac3ddbce-e2e2-4e32-ba19-ae080bf8d416

Route

TOPICAL

Published

Effective Date 2018-05-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (2 g) Zinc Cation (0.1 g)

Inactive Ingredients

Alcohol Glycerin Povidone Water Tromethamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-01-10

Description

Diphenhydramine HCl – 2% Topical analgesic Zinc Acetate – 0.1% Skin Protectant

Purpose

Diphenhydramine HCl – 2% Topical analgesic Zinc Acetate – 0.1% Skin Protectant

Medication Information

Purpose

Diphenhydramine HCl – 2% Topical analgesic Zinc Acetate – 0.1% Skin Protectant

Description

Diphenhydramine HCl – 2% Topical analgesic Zinc Acetate – 0.1% Skin Protectant

Uses

temporarily relieves itching and pain associated with minor irritations, burns, scrapes, cuts, insect bites and rashes due to poison oak & poison sumac. Dries the oozing and weeping of poison ivy, poison oak & poison sumac.

Section 50565-1

Keep out of reach of the children

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

Section 50566-9

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days

• symptoms persist more than 7 days or clear up and occur again within a few days

Section 50567-7

When using this product • avoid contact with eyes

Section 50570-1

Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body

Section 51945-4

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

Other Information

Store at 20^o - 25^oC (68^o - 77^oF)

Inactive Ingredients

Alcohol, Glycerin, Povidone, Purified Water, Tromethamine

Ask A Doctor Before Use

• on chicken pox

• on measles

Active Ingredients Purpose

Diphenhydramine HCl – 2% Topical analgesic

Zinc Acetate – 0.1% Skin Protectant

Structured Label Content

Uses

Section 50565-1 (50565-1)

Keep out of reach of the children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days

• symptoms persist more than 7 days or clear up and occur again within a few days

Section 50567-7 (50567-7)

When using this product • avoid contact with eyes

Section 50570-1 (50570-1)

Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body

Section 51945-4 (51945-4)

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

Other Information (Other information)

Store at 20^o - 25^oC (68^o - 77^oF)

Inactive Ingredients (Inactive ingredients)

Alcohol, Glycerin, Povidone, Purified Water, Tromethamine

Ask A Doctor Before Use (Ask a doctor before use)

• on chicken pox

• on measles

Active Ingredients Purpose (Active ingredients Purpose)

Diphenhydramine HCl – 2% Topical analgesic

Zinc Acetate – 0.1% Skin Protectant

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Alcohol", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Povidone", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Tromethamine", "unii": "023C2WHX2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves itching and pain associated with minor irritations, burns, scrapes, cuts, insect bites and rashes due to poison oak & poison sumac. Dries the oozing and weeping of poison ivy, poison oak & poison sumac.", "50565-1": "Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if • condition worsens or does not improve within 7 days • symptoms persist more than 7 days or clear up and occur again within a few days", "50567-7": "When using this product • avoid contact with eyes", "50570-1": "Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body", "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", "Other information": "Store at 20 o - 25 o C (68 o - 77 o F)", "Inactive ingredients": "Alcohol, Glycerin, Povidone, Purified Water, Tromethamine", "Ask a doctor before use": "• on chicken pox • on measles", "Active ingredients Purpose": "Diphenhydramine HCl – 2% Topical analgesic Zinc Acetate – 0.1% Skin Protectant"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.225528 · Updated: 2026-03-14T22:55:07.187033