MAXIMUM STRENGTH CORTISONE CREAM WITH ALOE- hydrocortisone cream cream

Maximum Strength Cortisone Cream with Aloe by

Drug Labeling and Warnings

Maximum Strength Cortisone Cream with Aloe by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, 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

Store at room temperature 59o-86oF (15o-30oC).  Protect from freezing.

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

Inactive Ingredients

aloe vera concentrate, 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 CORTISONE CREAM WITH ALOE 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-630
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)	79.18 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
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 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: 69842-630-03	1 in 1 CARTON	11/01/2016
1	NDC: 69842-630-01	28 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	11/01/2016

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(69842-630)