ANTI ITCH- hydrocortisone cream 
Meijer Distribution 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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Meijer Distribution, 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. Consult a doctor.
for the treatment of diaper rash. Consult 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 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
rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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, consult 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: consult a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, aloe barbadensis leaf juice

Questions or comments?

1-800-719-9260

Principal Display Panel

MAXIMUM STRENGTH

anti-itch cream

Hydrocortisone 1%

DOCTOR RECOMMENDED #1 anti-itch active ingredient

Relieves Itch Fast | With Soothing Aloe

INSECT BITES | POISON IVY | ECZEMA & PSORIASIS

Compare to Cortizone-10®

active ingredient

MAXIMUM STRENGTH

anti-itch cream

Hydrocortisone 1%

NET WT 2 OZ (56 g)

Relieves Itch Fast | With Soothing Aloe

INSECT BITES | POISON IVY | ECZEMA & PSORIASIS

anti - itch cream image
ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0319-01 in 1 CARTON03/23/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:79481-0319-11 in 1 CARTON03/25/2021
256 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/23/2021
Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2021
Document Id: 689acccf-1037-4e0e-a5b6-353faec3ef8c
Set id: 00040bfe-001a-484e-bec0-e21e8b27f369
Version: 3
Effective Time: 20211103
 
Meijer Distribution Inc