ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream

Anti-Itch by

Drug Labeling and Warnings

Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%

PURPOSE

Purpose

Topical Analgesic

Skin Protectant

INDICATIONS & USAGE

Uses

For the temporary relief of pain and itching associated with:

• minor skin irritation
• allergic itches
• rashes
• hives
• minor burns
• insect bites
• poison ivy
• poison oak
• poison sumac

WARNINGS

Warnings

DO NOT USE

Do not use on children under 2 years of age.

For external use only

• avoid contact with eyes
• do not apply to open wound or damaged skin.

STOP USE

Stop use and ask a doctor

• if condition worsens
• symptoms persist for 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

• For children under 2 years of age: consult a physician.

SPL UNCLASSIFIED SECTION

Other information

• Store at 20ºC to 25ºC (68ºF to 77ºF).

INACTIVE INGREDIENT

Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	0.02 g  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-20 STEARATE (UNII: NBX892EA57)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-023-37	1 in 1 BOX
1	NDC: 52000-023-39	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	04/15/2015

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52000-023)