ALOE CORT CALMING CREAM- hydrocortisone cream cream 
USRX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Aloe Cort Calming Cream
1905

Aloe Cort Update

ACTIVE INGREDIENT -

Hydrocortisone USP 1%​

Anti-itch

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
•eczema
•psoriasis​

For external use only

Do not use
•for the treatment of diaper rash. Ask a doctor.
•in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product
•avoid contact with the eyes
•do not use more than directed unless told to do so by a doctor
•do not put directly into the rectum by using fingers or any mechanical device or applicator

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

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

or 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: do not use, 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​

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

ALOE CORT CALMING CREAM 
hydrocortisone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70809-1905
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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)  
SQUALENE (UNII: 7QWM220FJH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70809-1905-160 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/201901/01/2022
Labeler - USRX LLC (115270633)
Registrant - USRX LLC (115270633)

Revised: 1/2021
 
USRX LLC