Allergy Cream with Zinc Acetate

Anti-Itch Maximum Strength by

Drug Labeling and Warnings

Anti-Itch Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Fred's Inc., Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-ITCH MAXIMUM STRENGTH- diphenhydramine hydrochloride and zinc acetate cream 
Fred's Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Allergy Cream with Zinc Acetate

Active Ingredients

Diphenhydramine hydrochloride 2%
Zinc acetate 0.1%

Purpose

Topical analgesic
Skin protectant

Uses

For the temporary relief of pain and itching associated with
minor burns   sunburn   minor cuts   scrapes   insect bites   minor skin irritations
rashes due to poison ivy, oak and sumac
dries the oozing and weeping of poison:   ivy  oak  sumac

Warnings

For external use only

  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

When using this product

avoid contact with the eyes

  Stop use and ask a doctor if

• condition gets worse
• symptoms last more than 7 days or clear up and come back within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

do not use more often 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: ask a doctor

Other information

Store between 59°-86°F (15°-30°C).

Inactive ingredients

cetyl alcohol, methylparaben, polysorbate 60, propylene glycol, purified water, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred’s Pharmacy

NDC: 55315-525-56

RELIEVES ITCHING FROM INSECT BITES & SKIN IRRITATION

Extra Strength
Anti-Itch Cream
(DIPHENHYDRAMINE HYDROCHLORIDE, USP 2% / ZINC ACETATE, USP 0.1%)
TOPICAL ANALGESIC / SKIN PROTECTANT

NET WT 1 OZ (28g)

Compare To The Active Ingredients In:
*Benadryl® Extra Strength Itch Stopping Cream

carton

ANTI-ITCH MAXIMUM STRENGTH 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-525-56	1 in 1 CARTON	08/08/2008	01/01/2020
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	08/08/2008	01/01/2020

Labeler - Fred's Inc. (005866116)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 5/2019

Document Id: 3f8fecf3-09b3-4e69-abf2-5ce2d222a460

34390-5

Set id: 1976e37b-8094-4ba0-91ee-09d1f3dbaf19

Version: 10

Effective Time: 20190529

 

Fred's Inc.