Extra Strength Itch Stopping Cream Drug Facts

SPL v3

SPL

SPL Set ID 4b2a349b-93ce-5ef5-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2014-03-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (20 mg) Zinc Cation (1 mg)

Inactive Ingredients

Diazolidinyl Urea Glyceryl Monostearate Methylparaben Water Propylparaben Propylene Glycol Peg-40 Stearate Peg-100 Stearate Cetyl Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-03-17

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Purpose

Diphenhydramine hydrochloride...............Topical anagesic Zinc acetate..............................................Skin protectant

Medication Information

Purpose

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Uses

temporarliy relieves pain and itching due to:

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 due to poison:

ivy
oak
sumac

Warnings

For external use only

Directions

do not use more often than directed
adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor

Do Not Use

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

Package Label

Extra Strength

Est. 1892 WEEKS&LEO Professional Health

ITCH STOPPING CREAM

Topical Analgesic / Skin Protectant

Net wt. 1 oz (28 g)

Other Information

store at 20º C to 25º C (68º F to 77º F)

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

Ask A Doctor Before Use

on chicken pox
on measles

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If

condition worsens
symptoms last 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

Uses

temporarliy relieves pain and itching due to:

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 due to poison:

ivy
oak
sumac

Purpose

Diphenhydramine hydrochloride...............Topical anagesic

Zinc acetate..............................................Skin protectant

Warnings

For external use only

Directions

do not use more often than directed
adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor

Do Not Use (Do not use)

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

Package Label

Extra Strength

Est. 1892 WEEKS&LEO Professional Health

ITCH STOPPING CREAM

Topical Analgesic / Skin Protectant

Net wt. 1 oz (28 g)

Other Information

store at 20º C to 25º C (68º F to 77º F)

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

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

on chicken pox
on measles

When Using This Product (When using this product)

do not get into eyes

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

condition worsens
symptoms last 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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarliy relieves pain and itching due to: 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 due to poison: ivy oak sumac", "Purpose": "Diphenhydramine hydrochloride...............Topical anagesic Zinc acetate..............................................Skin protectant", "Warnings": "For external use only", "Directions": "do not use more often than directed adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor", "Do not use": "on large areas of the body with any other product containing diphenhydramine, even one taken by mouth", "Package Label": "Extra Strength Est. 1892 WEEKS&LEO Professional Health ITCH STOPPING CREAM Topical Analgesic / Skin Protectant Net wt. 1 oz (28 g)", "Other Information": "store at 20º C to 25º C (68º F to 77º F)", "Active Ingredients": "Diphenhydramine hydrochloride 2% Zinc acetate 0.1%", "Inactive Ingredients": "cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water", "Ask a doctor before use": "on chicken pox on measles", "When using this product": "do not get into eyes", "Stop use and ask a doctor if": "condition worsens symptoms last 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: 2026-02-15T11:56:17.350862 · Updated: 2026-03-14T22:54:40.661795