WHITE PETROLATUM- cheryllee md sensitive skin care truelipids truelips lip balm ointment
Claridei Laboratories, Inc.

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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CheryLee MD TrueLipids TrueLips Lip Balm

Active Ingredient

White Petrolatum 50%

Purpose

Skin Protectant (ointment)

Uses

helps prevent and temporarily protect chafed, chapped, cracked lips
helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Keep out of reach of children

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

Directions

apply as needed day or night

Inactive Ingredients

Carpylic/Capric Triglyceride(Coconut), Coco-Caprlyate (Coconut), Microcrystalline Wax, Parrafin Wax, Euphorbia Cerifera (Candililla) Wax, C10-C30 Cholesterol/Lanosterol Esters, Ceramide 3, Phytosphingosine, Isostearyl Isostearate, Glycyrrhetinic Acid(Licorice Root)

TrueLipids TrueLips Lip Balm

WHITE PETROLATUM
cheryllee md sensitive skin care truelipids truelips lip balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61387-250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	50 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE 3 (UNII: 4370DF050B)
COCO-CAPRYLATE (UNII: 4828G836N6)
CANDELILLA WAX (UNII: WL0328HX19)
ENOXOLONE (UNII: P540XA09DR)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61387-250-02	1 in 1 CARTON	03/01/2014
1	NDC:61387-250-01	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M015	03/01/2014

Labeler - Claridei Laboratories, Inc. (035627639)