HYDROCORTISONE by ALLIED TRADE LINK LLC / GOLPALDAS VISRAM AND COMPANY LIMITED HYDROCORTISONE cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by ALLIED TRADE LINK LLC, GOLPALDAS VISRAM AND COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Purpose
Hydrocortisone USP 1% ............................................................................................................................................................................................................................................ Antipruritic (Anti-Itch)
Uses
For 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, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

WARNINGS

For External Use Only
If pregnant or breast-feeding, ask a health professional before use
Do not use In the eyes For diaper rash For external genital or feminine itching if you have a vaginal discharge More than the recommended
daily dosage unless directed by a doctor This product in the rectum by using fingers or any mechanical device or applicator
Ask a doctor before use if you are using any other hydrocortisone product
Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not
continue to use this or any other hydrocortisone product for longer than 7 days) Bleeding occurs due to anal itching

INACTIVE INGREDIENT

nactive Ingredients Aloe Vera, Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

INDICATIONS & USAGE

For 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, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

antipruritic (Anti-Itch

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84387-005
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84387-005-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	11/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/12/2024

Labeler - ALLIED TRADE LINK LLC (029033682)

Registrant - ALLIED TRADE LINK LLC (029033682)

Establishment
Name	Address	ID/FEI	Business Operations
GOLPALDAS VISRAM AND COMPANY LIMITED		858030888	manufacture(84387-005)