Hy-Vee, Inc. Anti-Itch Cream Drug Facts

Anti Itch by

Drug Labeling and Warnings

Anti Itch by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI ITCH- hydrocortisone 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.

----------

Hy-Vee, Inc. Anti-Itch Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• psoriasis
• poison ivy, oak, sumac
• insect bites
• detergents
• jewelry
• cosmetics
• soaps
• seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area if you have a vaginal discharge. Ask a doctor.
• for the treatment of diaper rash. Ask a doctor.

When using this product

• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• condition worsens
• rectal bleeding occurs
• symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep out of reach of children.

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

Directions

• for itching of skin irritation, inflammation, and rashes:
• 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: do not use, ask a doctor
• for external anal and genital itching, adults:
• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredient of Cortizone-10®

Maximum Strength

Anti-Itch Cream

Hydrocortisone 1%

With Aloe

Relieves Itch Fast

#1 Doctor Recommended Anti-Itch Active Ingredient

Skin Irritation & Rashes

Inflammation & Redness

Insect Bites & Poison Ivy

Eczema & Psoriasis

NET WT 1 OZ (28 g)

ANTI ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-319-64	1 in 1 CARTON	11/01/2015	04/12/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42507-319-26	2 in 1 CARTON	10/28/2016	10/28/2016
2		56 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	11/01/2015	04/12/2020

Labeler - HyVee Inc (006925671)

Revised: 11/2019

Document Id: d8a2445c-e80d-45a4-a6cc-db569c7e40ed

34390-5

Set id: ae31f1f5-db70-45cf-850e-67bfe6860748

Version: 3

Effective Time: 20191115

 

HyVee Inc