ANTI-ITCH REGULAR STRENGTH- hydrocortisone cream

Anti-Itch Regular Strength by

Drug Labeling and Warnings

Anti-Itch Regular Strength by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Hydrocortisone 0.5%..................................................Anti-itch

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT USE

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.
• more than directed unless directed by a doctor.

WHEN USING

When using this product

• avoid contact with eyes
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

Inactive ingredients aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-ITCH REGULAR STRENGTH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-192-57	1 in 1 CARTON	03/02/2020
1		57 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	03/02/2020

Labeler - CVS Pharmacy (062312574)