ALOE CORT- hydrocortisone cream

Aloe Cort by

Drug Labeling and Warnings

Aloe Cort by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic cream

Uses

For the temporary relief of itching from minor skin irritations, and rashes

• Other uses of this product should be only under the supervision of a doctor.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily, or as directed. Consult a physician for children under 2 years of age.

Warnings

• For external use only
• Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, stop use of this product and consult a physician
• Do not use for treatment of diaper rash

• Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Imidazolidinyl Urea, Methylparaben, PPG-2 Myristyl Ether Propionate, Polysorbate-60, Propylparaben, Purified Water, Squalane, Triethanolamine.

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

DERMA
TOPIX

aloe cort cream

Hydrocortisone USP, 1%

Net wt. 2 oz. (57g)

Topix Pharmaceuticals, Inc. N. Amityville, NY 11701

DERMA
TOPIX

INGREDIENTS AND APPEARANCE

ALOE CORT 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.57 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
Yellow Wax (UNII: 2ZA36H0S2V)
Benzyl Alcohol (UNII: LKG8494WBH)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Glycerin (UNII: PDC6A3C0OX)
Imidurea (UNII: M629807ATL)
Methylparaben (UNII: A2I8C7HI9T)
PPG-2 Myristyl Ether Propionate (UNII: 88R97D8U8A)
Polysorbate 60 (UNII: CAL22UVI4M)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Squalane (UNII: GW89575KF9)
Trolamine (UNII: 9O3K93S3TK)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-108-57	57 g in 1 TUBE; Type 0: Not a Combination Product	02/27/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	02/27/1990

Labeler - Topiderm, Inc. (049121643)