Diphenhydramine Hcl 2 % + Zinc Acetate 0.1%, A+ Health

Diphenhydramine Hcl 2 % + Zinc Acetate 0.1%, A+ Health
SPL v1
SPL
SPL Set ID 178ed513-4f22-8f11-e063-6294a90a109b
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (1 mg) Diphenhydramine (20 mg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Cetyl Alcohol Glycerin Glyceryl Monostearate Light Mineral Oil Methylparaben Polysorbate 60 Propylparaben Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-16

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

■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac

■ temporarily relieves pain and itching associated with:

■ minor cuts ■ sunburn ■ scrapes

■ minor skin irritations ■ minor burns ■ insect bites

■ rashes due to poison ivy, poison oak and poison sumac

Section 42229-5

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

MADE IN INDIA

GUJ/DRUGS/G/25/2134

L0000814

R0424

LOT & EXP.

Warnings

For external use only.

Do not use

■ with any other product containing diphenhydramine, even one taken by mouth

■ on large areas of the body

■ on broken, blistered, or oozing skin

Directions

■ children under 2 years of age: ask a doctor

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

■ do not use more than directed

Tube Carton

* compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream

NDC 69452-449-37

a+ health TM

itch relief cream

diphenhydramine HCl 2 % + zinc acetate 0.1%

net wt. 1.25 oz

dye-free • phthalate-free • fragrance-free

• extra strength

• topical analgesic

• skin protectant

Active Ingredient

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Other Information

■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use

■ Lot No. & Exp. Date: See box or crimp of tube

Inactive Ingredients

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60,

propylparaben, purified water, stearic acid

Ask A Doctor Before Use

■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn

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

■ 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

Uses

■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac

■ temporarily relieves pain and itching associated with:

■ minor cuts ■ sunburn ■ scrapes

■ minor skin irritations ■ minor burns ■ insect bites

■ rashes due to poison ivy, poison oak and poison sumac

Section 42229-5 (42229-5)

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Benadryl® Extra Strength ItchStopping Cream.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

MADE IN INDIA

GUJ/DRUGS/G/25/2134

L0000814

R0424

LOT & EXP.

Purpose

Topical Analgesic

Skin Protectant

Warnings

For external use only.

Do not use

■ with any other product containing diphenhydramine, even one taken by mouth

■ on large areas of the body

■ on broken, blistered, or oozing skin

Directions

■ children under 2 years of age: ask a doctor

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

■ do not use more than directed

Tube Carton (tube carton)

* compare to the active ingredient in Benadryl® Extra Strength Itch Stopping Cream

NDC 69452-449-37

a+ health TM

itch relief cream

diphenhydramine HCl 2 % + zinc acetate 0.1%

net wt. 1.25 oz

dye-free • phthalate-free • fragrance-free

• extra strength

• topical analgesic

• skin protectant

Active Ingredient (Active ingredient)

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Other Information (Other information)

■ Store at 15° to 30°C (59° to 86°F) ■ Close the cap tightly after use

■ Lot No. & Exp. Date: See box or crimp of tube

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type c, cetyl alcohol, glycerin, glyceryl monostearate, light mineral oil, methylparaben, polysorbate 60,

propylparaben, purified water, stearic acid

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

■ on measles ■ on chicken pox ■ on poison ivy ■ on sunburn

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

■ 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


Raw Label Data

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