HYDROCORTISONE- hydrocortisone 1% cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance LLC, 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

If Swallowed, get medical help or contact a Poison Control Center Immediately.

Uses

For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to

• Eczema
• Insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry
• seborrheic dermatitis
• psoriasis
• external feminine, 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

Do not use

• For the treatment of diaper rash, consult a doctor
• For external genital itching, if you have a vaginal discharge, consult a doctor

When using this Product

• Avoid contact with the eyes.
• Do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
• For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor
• 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 if

• Conditions worsen
• Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

Directions

Adults and children 2 years and older

• Apply to affected area not mroe than 3 to 4 times daily.

Children under 2 years of age

• Do not use
• Consult a doctor

For External and Anal Itching

• Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Children under 12 years of age with external anal itching; consult a doctor.

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Aloe Barbadensis leaf juice, Cetostearyl alcohol, Edtate disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Monostearate, White Petrolatum

Questions

Call 1-866-923-4914

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Other Information

This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10® Aloe

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

Product of PRC

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-529
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-529-01	1 in 1 BOX	01/09/2020
1		28 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	01/09/2020

Labeler - Pharmacy Value Alliance LLC (101668460)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)