SMARTCHOICES LANOLIN PLUS 0- lanolin cream
Florri Feme 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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Directions

Apply 0.15g once a day.

Smooth onto nipple area as needed

For external use

Inactive Ingredient

Caprylic capric triglyceride 50%

USEAGE

Helps prevent and treat sore nipples due to breast feeding

Purpose

Helps prevent and treat sore nipples due to breast feeding

Warning

Keep out of reach of children

Active Ingredient

Lanolin usp 50%

Ultra pure Lanolin

Reverse of packaging Kamolan, Lanolin (ultra pure pharmacetical grade, USP modified Lanolin) Caprylic Capric Triglyceride (fractioned coconut oil)

Front of packaging

SMARTCHOICES LANOLIN PLUS 0
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70196-1333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	1 mg in 50 mg

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70196-1333-2	2 mg in 1 PACKET; Type 0: Not a Combination Product	10/10/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/01/2010

Labeler - Florri Feme Pharmaceuticals Ltd (213924185)

Registrant - Florri Feme Pharmaceuticals Ltd (213924185)

Name	Address	ID/FEI	Business Operations
Establishment
Florri Feme Pharmaceuticals Ltd		213924185	manufacture(70196-1333)