HYDROCORTISONE by CVS PHARMACY, INC HYDROCORTISONE cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each gram)

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  sunburn  detergents  jewelry  cosmetics  soaps  seborrheic dermatitis  temporarily relieves external anal and genital itching  other uses of this product should be under 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 persists 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 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 room temperature 68°-77°F(20°-25°C).
• tamper-evident: do not use if foil seal is broken or missing.

Inactive ingredients

2-phenoxyethanol, aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, ginger oil, glycerin, glyceryl stearate, maltodextrin, methyl gluceth-20, methylparaben, methylpentadecane, petrolatum, polysorbate 80, propylene glycol, purified water, stearic acid, trisodium citrate dihydrate, vitamin E

Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETIC ACID (UNII: 9G34HU7RV0)
ETHYLPARABEN (UNII: 14255EXE39)
GINGER OIL (UNII: SAS9Z1SVUK)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-227-00	1 in 1 BOX	10/15/2022
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 Drug	M017	10/15/2022

Labeler - CVS PHARMACY, INC (062312574)