ANTI-ITCH CREAM- diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream

Anti-Itch Cream by

Drug Labeling and Warnings

Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic

Active Ingredient

Zinc Acetate 0.1%

Purpose

Skin Protectant

INDICATIONS & USAGE

For the temporary relief from pain and itching associated with

• insect bites
• minor burns
• minor skin irritation
• rashes due to poison ivy, poison oak, and poison sumac
• dries the weeping and oozing of poison ivy, oak and sumac

Warnings

For External Use Only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use on chicken pox or measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

• Conditions worsen or do not improve within 7 days
• Symptoms persist for more than 7 days or clear up and occur again within a few days

Stop use and ask a doctor

• Conditions worsen or do 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 the reach of children

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

Directions

• Do not use more than directed
• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age: consult a doctor

Other information

• Store at controlled room temperature 20º-25ºC (68º-77ºF)
• Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

ANTI-ITCH CREAM 
diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-025
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 ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-23 (UNII: N72LMW566G)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-025-05	1 in 1 BOX	12/29/2016
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-025-15	1 in 1 BOX	02/11/2020
2		42 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 final	part347	12/29/2016

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)