sheffield extra strength anti- itch cream

SPL v3

SPL

SPL Set ID 77f0593e-f694-4c02-9fd9-ad56ff2a920c

Route

topical

Published

Effective Date 2023-10-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (20 mg) zinc cation (1 mg)

Inactive Ingredients

cetyl alcohol diazolidinyl urea methylparaben peg-20 stearate propylene glycol propylparaben water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2008-11-11

Purpose

Topical analgesic Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Medication Information

Warnings

For external use only

Do not use

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

Ask a Doctor before use

on chicken pox
on measles

When using this product avoid contact with eyes.

Stop use and ask a doctor if

conditions worsen or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur agian within a few days

Uses

For temporary relief from pain and itching associated with :

insect bites
minor burns
sunburn
minor skin irritations
rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

ivy
oak
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 areas not more than 3 to 4 times daily
children under 2 years of age , consult a doctor

Other Information

Store at controlled room temperature 20°-25°C (68° - 77°F)
Close the cap tightly after use

Inactive Ingredients

Cetyl Alcohol, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water

Description

Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%

Drug Facts:

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Principal Display Panel 1.25 Oz Tube

Sheffield Pharmaceuticals NDC 11527-069-04

2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate

ANTI-ITCH cream

Histamine blocker relieves itching from insect bites & skin irritations

Topical Analgesic & Skin Protectant

NET WT. 1.25oz ( 35g)

Principal Display Panel 1.25 Oz Carton

Sheffield Pharmaceuticals NDC 11527-069-04

ANTI -ITCH cream

Topical analgesic & Skin Protectant

Made in the USA NET WT. 1.25 oz ( 35g)

Keep This and All Drugs Out of the Reach of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only

Do not use

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

Ask a Doctor before use

on chicken pox
on measles

When using this product avoid contact with eyes.

Stop use and ask a doctor if

conditions worsen or does not improve within 7 days
symptoms persist for more than 7 days or clear up and occur agian within a few days

Uses

For temporary relief from pain and itching associated with :

insect bites
minor burns
sunburn
minor skin irritations
rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

ivy
oak
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 areas not more than 3 to 4 times daily
children under 2 years of age , consult a doctor

Other Information

Store at controlled room temperature 20°-25°C (68° - 77°F)
Close the cap tightly after use

Inactive Ingredients (Inactive ingredients)

Cetyl Alcohol, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water

Drug Facts:

Active Ingredients (Active ingredients)

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Principal Display Panel 1.25 Oz Tube (Principal Display Panel 1.25 oz Tube)

Sheffield Pharmaceuticals NDC 11527-069-04

2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate

ANTI-ITCH cream

Histamine blocker relieves itching from insect bites & skin irritations

Topical Analgesic & Skin Protectant

NET WT. 1.25oz ( 35g)

Principal Display Panel 1.25 Oz Carton (Principal Display Panel 1.25 oz Carton)

Sheffield Pharmaceuticals NDC 11527-069-04

ANTI -ITCH cream

Topical analgesic & Skin Protectant

Made in the USA NET WT. 1.25 oz ( 35g)

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

If swallowed get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "For temporary relief from pain and itching associated with : insect bites minor burns sunburn minor skin irritations rashes due to poison ivy, poison oak, and poison sumac Dries the oozing and weeping of poison ivy oak sumac", "Purpose": "Topical analgesic Skin protectant", "Warnings": "For external use only Do not use on large areas of the body with any other product containing diphenhydramine , even one taken by the mouth. Ask a Doctor before use on chicken pox on measles When using this product avoid contact with eyes. Stop use and ask a doctor if conditions worsen or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur agian within a few days", "Directions": "do not use more than directed adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily children under 2 years of age , consult a doctor Other Information Store at controlled room temperature 20°-25°C (68° - 77°F) Close the cap tightly after use", "Active ingredients": "Diphenhydramine hydrochloride 2% Zinc Acetate 0.1%", "Inactive ingredients": "Cetyl Alcohol, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water", "Principal Display Panel 1.25 oz Tube": "Sheffield Pharmaceuticals NDC 11527-069-04 2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate ANTI-ITCH cream Histamine blocker relieves itching from insect bites & skin irritations Topical Analgesic & Skin Protectant NET WT. 1.25oz ( 35g)", "Principal Display Panel 1.25 oz Carton": "Sheffield Pharmaceuticals NDC 11527-069-04 ANTI -ITCH cream Topical analgesic & Skin Protectant Made in the USA NET WT. 1.25 oz ( 35g)", "Keep this and all drugs out of the reach of children.": "If swallowed get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:10.670282 · Updated: 2026-03-14T23:01:36.166619