HYDROCORTISONE WITH ALOE- hydrocortisone cream 
Delsam Pharma 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.

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HYDROCORTISONE CREAM USP 1% WITH ALOE

Drug Facts

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 • insects 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 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 application of this product 

Children under 12 years of age: consult a doctor

Inactive ingredients

Aloe vera concentrate, Cetomacrogol 1000, Cetostearyl alcohol, White Petroleum Jelly, Propylene glycol, Light Liquid Paraffin, Monobasic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water

Other information

• Store at room temperature 59°-89°F (15°-30°C). Protect from freezing.

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

Questions or comments?

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

For Temporary relief of

* Skin irritations, Inflammation, & Rashes

* Insect Bites, Eczema & Psoriasis

Compare to the active ingredient in Cortaid Maximum Strength Cream *

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortaid®

Packaging

image description

HYDROCORTISONE WITH ALOE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHLOROCRESOL (UNII: 36W53O7109)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72570-106-301 in 1 CARTON09/25/201803/15/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/201803/15/2023
Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023
 
Delsam Pharma Llc