ANTI-ITCH CREAM- diphenhydramine hcl / zinc acetate cream

Anti-Itch Cream by

Drug Labeling and Warnings

Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by Front Pharmaceutical PLC, Front Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical Analgesic

Skin Protectant

Use

for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison:

• ivy
• oak
• sumac

WARNINGS

For external use only

Do not use

• over large areas of the body
• with any other product containing diphenhydramine, including those taken orally

When using this product

• avoid contact with eyes

Ask a doctor before use

• on chicken pox
• on measles

Stop use and ask a doctor if

• symptoms last for more than 7 days
• the condition gets worse
• symptoms clear up and then 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.

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day.
• children under 2 years of age: ask a doctor before use

Inactive ingredients

cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

Questions

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other information

• store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C).
• tamper-evident: do not use if foil seal is broken or missing.

PRINCIPAL DISPLAY PANEL

Extra Strength

Anti-Itch Cream

Topical Analgesic and Skin Protectant Cream

Net Wt 1 oz (28 g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH CREAM 
diphenhydramine hcl / zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
LAURETH-15 (UNII: 002FR4N8OV)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-011-01	1 in 1 BOX	09/25/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/25/2023

Labeler - Front Pharmaceutical PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
Front Pharmaceutical		530897792	manufacture(69571-011)