DZA Brands, LLC Anti-Itch Cream Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

HEALTHY ACCENTS ANTI ITCH- diphenhydramine hydrochloride, zinc acetate cream 
DZA Brands LLC

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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DZA Brands, LLC Anti-Itch 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?

1-866-322-2439

Principal Display Panel

Compare to Extra Strength Benadryl® Itch Stopping Cream active ingredients

extra strength

anti-itch cream

relieves itches from insect bites & skin irritations

topical analgesic

skin protectant

Anti-Itch Cream Carton Image 1

Anti-Itch Cream Carton Image 1

Anti-Itch Cream Carton Image 2

HEALTHY ACCENTS ANTI ITCH 
diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-622
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-622-64	1 in 1 CARTON	07/21/2010	08/31/2019
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	07/21/2010	08/31/2019

Labeler - DZA Brands LLC (090322194)

Revised: 12/2018

Document Id: 137b0278-383b-455a-8826-4a26fc5fa520

34390-5

Set id: 020e139a-6f0a-4c18-8169-d95e9b5dc7f4

Version: 2

Effective Time: 20181218

 

DZA Brands LLC