Rite Aid Anti-Itch Cream Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

HYDROSKIN- hydrocortisone cream 
Rugby Laboratories

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.

----------

Rite Aid Anti-Itch Cream 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

• for the treatment of diaper rash. Ask a doctor.
• in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

• avoid contact with the eyes
• for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly 
• do not insert cream 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

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: do not use, 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

• store at 15°-30°C (59°-86°F)
• see box or crimp of tube for lot number and expiration date

Inactive ingredients

emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcohol

Questions or comments?

1-800-645-2158

Principal Display Panel

Maximum Strength

Anti-Itch Cream

1% Hydrocortisone Anti-Itch Cream

HYDROSKIN 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-5108
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE (Off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-5108-95	1 in 1 CARTON	10/29/2012	11/30/2018
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	10/29/2012	11/30/2018

Labeler - Rugby Laboratories (079246066)

Revised: 9/2019

Document Id: e3c19c67-125f-4a34-b525-6d6ae53ca2a0

34390-5

Set id: f1e4ee6a-d58a-4c23-b389-d477acb60911

Version: 2

Effective Time: 20190906