HYDROCORTISONE ANTI-ITCH- hydrocortisone cream 
Universal Distribution Center 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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Hydrocortisone Anti-Itch Cream

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations and rashes due to:

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

For external use only

Do not use in genital area if you have a vaginal discharge.

Consult a doctor, for the treatment of diaper rash. Ask a doctor.

When using this product

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.

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: Ask a doctor

For external anal and genital itching, adults:

When practical, clean the affected area with mild soap and 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

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE ANTI-ITCH CREAM

NET WT 0.5 OZ. (14 g)

label

HYDROCORTISONE ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-022-371 in 1 BOX12/09/2020
1NDC:52000-022-3614 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 finalpart34812/09/2020
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-022)

Revised: 12/2020
Document Id: b6087eab-5f3b-e87e-e053-2995a90abb47
Set id: d44ee37a-305e-4adc-be42-4928d6771655
Version: 2
Effective Time: 20201209
 
Universal Distribution Center LLC