other information

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

Active Ingredient

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

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

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


Raw Label Data

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