Hy-Vee, Inc. Itch Stopping Cream Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ITCH STOPPING- diphenhydramine hydrochloride, zinc acetate cream 
HyVee 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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Hy-Vee, Inc. Itch Stopping Cream Drug Facts

Active ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

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

Directions

• do not use more than directed
• adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the active ingredients of Extra Strength Benadryl® Cream

Extra Strength

Itch Stopping Cream

Diphenhydramine HCl/Zinc Acetate

Fast Relief for Most Outdoor Itches

Topical Analgesic & Skin Protectant

Relieves Itches from Insect Bites & Skin Irritations

NET WT 1 OZ (28 g)

ITCH STOPPING 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-622
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
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
PEG-20 STEARATE (UNII: NBX892EA57)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-622-64	1 in 1 CARTON	09/27/2015	05/06/2019
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	09/27/2015	05/06/2019

Labeler - HyVee Inc (006925671)

Revised: 7/2019

Document Id: c47326ac-9133-40c2-9573-6b60a9610039

34390-5

Set id: 53157137-b980-45d2-aa10-8c111c0ec2f4

Version: 2

Effective Time: 20190725

 

HyVee Inc