HYDROCORTISONE ULTRA STRENGTH- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Anicare Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Drug Facts

Hydrocortisone 1%

Purpose

Anti itch

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

• eczema
• inset bites
• cosmetics
• psoriasis
• detergents
• soaps
• poison ivy, oak
• sumac
• jewelry
• 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 eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum

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

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: 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 between 59° and 86° F  (15° and 30° C)
• do not use if seal on tube is punctured or missing

Inactive ingredients

aloe vera gel, celeareth-20, cetyl alcohol, cetyl palitate, glycerin, isopropyl myristate, isodecyl neopentanoate, methyl paraben, purified water

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Hydrocortisone Cream

Fast Itch and Rash relief

Helps relieve

• Eczema
• Seborrheic dermatitis
• Psoriasis
• Poison ivy
• Poison oak
• Poison sumac
• Insect bites and more

NET WT. 0.5 OZ. (14 g)

Distributed by: PERSONAL CARE PRODUCTS, LLC  Troy, Michigan 48084 U.S.A.

Code No.:MH/DRUGS/KD-313      Made in India

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  ULTRA STRENGTH
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	140 mg  in 14 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2439-1	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/10/2013

Labeler - Personal Care Products, Inc. (966155082)

Registrant - Personal Care Products, Inc. (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd.		916837425	manufacture(29500-2439)