LINCOFIX- lanolin ointment
Lincoln Pharmaceuticals Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Lanolin 22%

Purpose

Skin Protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin
Temporarily protects minor cuts, scrapes, burns

Warnings

FOR EXTERNAL USE ONLY

When using this product

Avoid contact with eyes
If contact occurs, flush with water

Stop use and ask a doctor if

condition worsens
symptoms last more than seven days or clear up and occur again within seven days

Do not use on

deep or puncture wounds
lacerations
animal bites
serious burns

Keep out of reach of children

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

Directions

Apply as needed to clean skin twice daily or more often if necessary

For Children under 6 months ask a doctor

Inactive Ingredients

Aluminium Hydroxide, Alpha Tocopherol Acetate(Vitamin E), Calcium carbonate, Cholecalciferol (Vitamin D3), Citric Acid,Corn Oil, Ethylparaben, Lanolin, Magnesium Hydroxide, Methylparaben, Sodium Chloride, Sodium laureth Sulfate, Petrolatum, Vitamin A Palmitate, Water, Zinc Chloride

Product Label

LINCOFIX
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69636-8050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
ETHYLPARABEN (UNII: 14255EXE39)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CALCIUM CARBONATE (UNII: H0G9379FGK)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PETROLATUM (UNII: 4T6H12BN9U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ZINC CHLORIDE (UNII: 86Q357L16B)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69636-8050-2	113 g in 1 TUBE; Type 0: Not a Combination Product	10/06/2016
2	NDC:69636-8050-3	113 g in 1 JAR; Type 0: Not a Combination Product	10/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/06/2016

Labeler - Lincoln Pharmaceuticals Ltd. (915839373)