HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION, TARO PHARMACEUTICALS U.S.A., INC., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
• temporarily relieves external anal and genital itching
• other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• in the genital area 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 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
• rectal bleeding occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for 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: 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

Other information

• to open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
• store at 20° to 25° C (68° to 77° F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile oil, citric acid, corn oil, glycerin, glyceryl monostearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin wax, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A & vitamin D3 liquid, vitamin E, white petrolatum.

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319
www.riteaid.com

MADE IN CANADA

PRINCIPAL DISPLAY PANEL - 56.8 Tube Carton

MAXIMUM STRENGTH

HYDROCORTISONE CREAM 1%

PLUS 12 MOISTURIZERS

ANTI-ITCH

RELIEVES ITCH FAST

For skin irritations

Enriched with vitamins A, D3 & Vitamin E

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  PLUS 12 MOISTURIZERS
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-2090
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-2090-2	1 in 1 CARTON	07/21/2023
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11822-2090-3	1 in 1 CARTON	07/21/2023
2		56.8 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 Drug	M017	07/21/2023

Labeler - RITE AID CORPORATION (014578892)

Registrant - TARO PHARMACEUTICALS U.S.A., INC. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	manufacture(11822-2090)