HYDROCORTISONE WITH ALOE- hydrocortisone cream

Drug Details [pdf]

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

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.
SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HYDROCORTISONE WITH ALOE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	white (white to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72570-106-30	1 in 1 CARTON	09/25/2018
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/25/2018

Labeler - Delsam Pharma Llc (081369679)

HYDROCORTISONE WITH ALOE- hydrocortisone cream

HYDROCORTISONE WITH ALOE by

Drug Labeling and Warnings

Drug Details [pdf]