ALOE CORT- hydrocortisone cream 
Topiderm, Inc.

----------

Aloe Cort Cream

Drug Facts

Active ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic cream

Uses

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

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

  • 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

PRINCIPAL DISPLAY PANEL - 57 g Tube Label
ALOE CORT 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.57 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-108-5757 g in 1 TUBE; Type 0: Not a Combination Product02/27/1990
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01702/27/1990
Labeler - Topiderm, Inc. (049121643)
Registrant - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm, Inc.049121643MANUFACTURE(51326-108)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals, Inc.117745066PACK(51326-108)

Revised: 9/2019
Document Id: 5ddca73e-dfd3-446f-a0d2-3daadc9abddb
Set id: 789a6669-3320-4558-8d6f-ab255db50d8d
Version: 9
Effective Time: 20190917
 
Topiderm, Inc.