drug facts

drug facts

SPL v1

SPL

SPL Set ID 602c2a3a-557c-452d-a7ed-4e0e9c3b742f

Route

topical

Published

Effective Date 2011-08-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

diphenhydramine (2 g) zinc (.1 g)

Inactive Ingredients

cetyl alcohol diazolidinyl urea dodecyl-2-n,n-dimethylaminopropionate hydrochloride methylparaben peg-2 stearate peg-20 stearate propylene glycol propylparaben water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2011-08-29

Purpose

Topical Analgesic Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Medication Information

Warnings

For external use only.

Uses

For the temporary relief of itching and pain associated with:
insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Purpose

Topical Analgesic

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, or as directed by a doctor
children under 2 years of age, consult a doctor

Other Information

Store between 20^o and 25^oC (68^o to 77^oF)
Lot no. and Exp. Date: see box or see crimp of tube
Keep box for complete instructions and labeling

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Section 51945-4

Section 53413-1

Call 1-866-580-7391, Mon - Fri, 8:30 AM - 5:30 PM (PST)

Do Not Use

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

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Ask A Doctor Before Use

on chicken pox
on measles

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

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

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.

Uses

For the temporary relief of itching and pain associated with:
insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Purpose

Topical Analgesic

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, or as directed by a doctor
children under 2 years of age, consult a doctor

Other Information (Other information)

Store between 20^o and 25^oC (68^o to 77^oF)
Lot no. and Exp. Date: see box or see crimp of tube
Keep box for complete instructions and labeling

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-866-580-7391, Mon - Fri, 8:30 AM - 5:30 PM (PST)

Do Not Use (Do not use)

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

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

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

on chicken pox
on measles

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

[{"name": "Diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC", "unii": "J41CSQ7QDS", "classCode": "ACTIB", "strengthNumerator": ".1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride", "unii": "18F5YMF989", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-2 STEARATE", "unii": "94YQ11Y95F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-20 STEARATE", "unii": "NBX892EA57", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of itching and pain associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac", "53413-1": "Call 1-866-580-7391, Mon - Fri, 8:30 AM - 5:30 PM (PST)", "Purpose": "Topical Analgesic Skin protectant", "Warnings": "For external use only .", "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, or as directed by a doctor children under 2 years of age , consult a doctor", "Do not use": "on large areas of the body with any other product containing diphenhydramine, even one taken by mouth", "Other information": "Store between 20 o and 25 o C (68 o to 77 o F) Lot no. and Exp. Date: see box or see crimp of tube Keep box for complete instructions and labeling", "Active Ingredients": "Diphenhydramine hydrochloride 2% Zinc acetate 0.1%", "Inactive Ingredients": "cetyl alcohol, diazolidinyl urea, dodecyl-2-N,N-dimethylaminopropionate hydrochloride, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water", "Ask a doctor before use": "on chicken pox on measles", "When using this product": "avoid contact with the eyes", "Stop use and ask a doctor if": "condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days or clear up and occur again within a few days.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.556050 · Updated: 2026-03-14T22:52:49.153069