MAXIMUM STRENGTH HYDROCORTISONE CREAM- hydrocortisone cream cream

Maximum Strength Hydrocortisone Cream by

Drug Labeling and Warnings

Maximum Strength Hydrocortisone Cream by is a Otc medication manufactured, distributed, or labeled by Walgreens, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do not use

for external feminine itching 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 begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

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

Directions

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 itching - Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12  years of age: consult a doctor.

Other information

Storage temperature: not to exceed 30oC (86oF).  Protect from freezing.

Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH. 

Carton Label

Tube Label

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH HYDROCORTISONE CREAM 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1.02 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	79.28 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	7 g  in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X)	4 g  in 100 g
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)	0.5 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.2 g  in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	1.5 g  in 100 g
PEG-40 STEARATE (UNII: ECU18C66Q7)	0.5 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH)	1 g  in 100 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	4 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0638-04	1 in 1 CARTON	06/07/2016
1	NDC: 0363-0638-02	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	06/07/2016

Labeler - Walgreens (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(0363-0638)