HYDROCORTISONE 1% WITH HEALING ALOE- hydrocortisone cream

Hydrocortisone 1% with healing aloe by

Drug Labeling and Warnings

Hydrocortisone 1% with healing aloe by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:

● eczema        ● seborrheic dermatitis      ● psoriasis     ● insect bites    ● poison ivy, oak, sumac      ● soaps    

● detergents   ● cosmetics                        ● jewelry        ● external genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

●for external use only ● avoid contact with the eyes

●do not put this product into the rectum by using fingers or any mechanical device or applicator

● Stop using this product and ask a doctor ● in case of bleeding

● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

● before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age

For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor

● in case of bleeding, consult a doctor promptly

● do not put this product into the rectum by using fingers or any mechanical device or applicator

● children under 12 years of age: consult a doctor

Before using any medication, read all label directions. Keep this carton. It contains important information.

Directions

●when practical, cleanse 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.

●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

●children under 12 years of age: do not use, consult a doctor.

Inactive ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

Other information

● to open: unscrew cap and pull tab to remove foil seal

● if seal has been broken, do not use this product. Return product to the Store where you bought it

● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)

see carton or tube crimp for lot number and expiration date

SPL UNCLASSIFIED SECTION

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% WITH HEALING ALOE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-005
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-005-20	1 in 1 BOX	12/23/2015
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-005-05	1 in 1 BOX	08/23/2016
2		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/23/2015

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)