Other Information

SPL v1

SPL

SPL Set ID 05d3f15b-bb34-191a-e063-6294a90a3b4a

Route

TOPICAL

Published

Effective Date 2023-09-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison: ivy oak sumac

Dosage and Administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day. children under 2 years of age: ask a doctor before use

Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Section 44425-7

store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C). tamper-evident: do not use if foil seal is broken or missing.

Section 50565-1

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

Section 50566-9

symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days

Section 50567-7

avoid contact with eyes

Section 50569-3

on chicken pox on measles

Section 50570-1

over large areas of the body with any other product containing diphenhydramine, including those taken orally

Section 51727-6

cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

Section 51945-4

Extra Strength Anti-Itch Cream Topical Analgesic and Skin Protectant Cream Net Wt 1 oz (28 g)

Section 53413-1

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Section 55105-1

Topical Analgesic Skin Protectant

Section 55106-9

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Structured Label Content

Indications and Usage (34067-9)

for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison: ivy oak sumac

Dosage and Administration (34068-7)

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day. children under 2 years of age: ask a doctor before use

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C). tamper-evident: do not use if foil seal is broken or missing.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days

Section 50567-7 (50567-7)

avoid contact with eyes

Section 50569-3 (50569-3)

on chicken pox on measles

Section 50570-1 (50570-1)

over large areas of the body with any other product containing diphenhydramine, including those taken orally

Section 51727-6 (51727-6)

cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

Section 51945-4 (51945-4)

Extra Strength Anti-Itch Cream Topical Analgesic and Skin Protectant Cream Net Wt 1 oz (28 g)

Section 53413-1 (53413-1)

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Section 55105-1 (55105-1)

Topical Analgesic Skin Protectant

Section 55106-9 (55106-9)

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Raw Label Data

All Sections (JSON)

{"34067-9": "for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison: ivy oak sumac", "34068-7": "adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day. children under 2 years of age: ask a doctor before use", "34071-1": "For external use only", "44425-7": "store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C). tamper-evident: do not use if foil seal is broken or missing.", "50565-1": "If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days", "50567-7": "avoid contact with eyes", "50569-3": "on chicken pox on measles", "50570-1": "over large areas of the body with any other product containing diphenhydramine, including those taken orally", "51727-6": "cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol", "51945-4": "Extra Strength Anti-Itch Cream Topical Analgesic and Skin Protectant Cream Net Wt 1 oz (28 g)", "53413-1": "1-800-639-3803 Weekdays 9 AM to 4 PM EST", "55105-1": "Topical Analgesic Skin Protectant", "55106-9": "Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:18.300221 · Updated: 2026-02-15T12:01:17.882700