ALOE CORT CALMING CREAM- hydrocortisone cream cream

Aloe Cort Calming Cream by

Drug Labeling and Warnings

Aloe Cort Calming Cream by is a Otc medication manufactured, distributed, or labeled by USRX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ALOE CORT CALMING CREAM 
hydrocortisone cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1905-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/08/2019

Labeler - USRX LLC (115270633)

Registrant - USRX LLC (115270633)