LINCOLN- hydrocortisone acetate cream

Lincoln by

Drug Labeling and Warnings

Lincoln by is a Otc medication manufactured, distributed, or labeled by Lincoln Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Hydrocortisone Acetate USP (1 % W/W)

Drug Facts

Anti-Itch

Drug Facts

for external use only

INDICATIONS & USAGE

USES

• For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy position sumac, poison oak, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Drug Facts

• in the eyes
• for diaper rash
• if you have a vaginal discharge
• more than the recommended dosage

Drug Facts

If you are pregnant or breast- feeding

Drug Facts

• the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Drug Facts

• If swallowed, get medical help or contact a Poison Control Center right away

Drug facts

For Itching of skin irritation, inflammation and rashes:

• adults and children over 2 years of age
• apply evenly to affected area no more than 3 to 4 times daily

Children under 2 years of age

• Do not use, consult a doctor

For External anal and genital itching, adults:

• when practical cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry, patting or blotting with bathroom tissue or soft cloth before applying
• apply externally to the area upto 6 times daily or after each bowel movement
• after application, discard pad
• do not flush in toilet

Drug Facts

Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Drug Facts:

• store at room temperature 68-77 F (20°-25°C)
• avoid excessive heat and humidity

Package Label

INGREDIENTS AND APPEARANCE

LINCOLN 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69636-3050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHLOROCRESOL (UNII: 36W53O7109)
CETETH-20 (UNII: I835H2IHHX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69636-3050-2	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/23/2013
2	NDC: 69636-3050-3	28.3 g in 1 TUBE; Type 0: Not a Combination Product	05/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/23/2013

Labeler - Lincoln Pharmaceuticals Ltd. (915839373)

Establishment
Name	Address	ID/FEI	Business Operations
Lincoln Pharmaceuticals Ltd.		915839373	manufacture(69636-3050)