Hydrocortisone by Mericon Industries HYDROCORTISONE lotion

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Mericon Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

• For external use only
• avoid contact with the eyes

Stop using this product 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
• before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

• if you have a vaginal discharge
• before treating diaper rash
• before using on children under 2 years of age

For external anal itching users

• do not exceed the recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Keep this and all drugs out of the reach of children

Directions

• 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, consult a doctor

For External Anal Itching Users

• adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• children under 12 years of age: consult a doctor

Other Information

• store at 55 to 76F

Inactive Ingredients

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

PRINCIPAL DISPLAY PANEL - 114 g Bottle Label

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%
Lotion

Anti-Itch
Poison Ivy
Poison Oak
Poison Sumac
Hives Rashes

Net Wt. 4 oz. (114g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0394-0859
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	1.14 g  in 114 g

Inactive Ingredients
Ingredient Name	Strength
stearic acid (UNII: 4ELV7Z65AP)
propylene glycol (UNII: 6DC9Q167V3)
lanolin alcohols (UNII: 884C3FA9HE)
mineral oil (UNII: T5L8T28FGP)
MYRISTIC ACID (UNII: 0I3V7S25AW)
cetyl alcohol (UNII: 936JST6JCN)
polysorbate 80 (UNII: 6OZP39ZG8H)
sorbitan monooleate (UNII: 06XEA2VD56)
water (UNII: 059QF0KO0R)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0394-0859-32	12 in 1 BOX	06/12/2023
1		114 g in 1 BOTTLE, DISPENSING; 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	06/12/2023

Labeler - Mericon Industries (059943670)

Establishment
Name	Address	ID/FEI	Business Operations
Mericon Industries		059943670	MANUFACTURE(0394-0859)