Itch Stopping Cream

Itch Stopping Cream
SPL v2
SPL
SPL Set ID 05ee2662-6a51-6e49-e063-6294a90a4ed7
Route
TOPICAL
Published
Effective Date 2014-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Zinc Cation (0.1 g)
Inactive Ingredients
Cetyl Alcohol Diazolidinyl Urea Methylparaben Propylene Glycol Propylparaben Water Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-22

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Purpose

Topical analgesic Skin protectant


Medication Information

Purpose

Topical analgesic

Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Uses

■  temporarily relieves pain and itching 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

Warnings

For external use only

Directions

■ do not use more than directed 

■ adults and children2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

Do Not Use

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

Ask a doctor before use■ on chicken pox ■ on measles

Package Label

Active Ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Other Information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, propylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Ask A Doctor Before Use

avoid contact with eyes

Stop Use and Ask A Doctor If

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

■  temporarily relieves pain and itching 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

Warnings

For external use only

Directions

■ do not use more than directed 

■ adults and children2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: 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

Ask a doctor before use■ on chicken pox ■ on measles

Package Label

Active Ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Other Information (Other information)

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, propylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

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

avoid contact with eyes

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

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


Raw Label Data

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