EQUATE HYDROCORTISONE TOPICAL- hydrocortisone cream

Equate Hydrocortisone by

Drug Labeling and Warnings

Equate Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by WalMart, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
• and for external anal and genital itching

Warnings

For external use only.

Avoid contact with eyes.

Do not use

• if you have a vaginal discharge. Consult a doctor.

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor
• do not put 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
• bleeding occurs

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

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

Directions

For itching associated with minor skin irritations, 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: Consult a doctor

For external anal and genital itching: Adults and children 12 years of age and older:

• when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information

• store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

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SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 28 g Bottle Carton

NDC: 79903-091-01

equate™

Compare to
Cortaid®
active
ingredient*

MAXIMUM STRENGTH

Hydrocortisone
Cream

Relief In A Soothing &
Cooling Cream

Fast Itch Relief:

• Eczema
• Psoriasis
• Seborrheic Dermatitis
• Soaps
• Insect Bites
• Poison Ivy, Oak & Sumac
• And More

NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

EQUATE HYDROCORTISONE   TOPICAL
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
cetyl alcohol (UNII: 936JST6JCN)
DMDM hydantoin (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
isopropyl alcohol (UNII: ND2M416302)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
propylparaben (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
stearic acid (UNII: 4ELV7Z65AP)
2,2'-((2-(DODECYLOXY)ETHYL)IMINO)BISETHANOL (UNII: 5MYL465X9V)
EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79903-091-01	1 in 1 CARTON	11/17/2021
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 79903-091-04	2 in 1 CARTON	11/17/2021
2		56 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	11/17/2021

Labeler - WalMart (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(79903-091)