TRUELIPIDS TRUELIPS LIP BALM CL MD- white petrolatum solution

Truelipids TrueLips Lip Balm by

Drug Labeling and Warnings

Truelipids TrueLips Lip Balm by is a Otc medication manufactured, distributed, or labeled by Claridei Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient purpose

White Petrolatum 50% Skin Protectant (ointment)

PURPOSE

Uses

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS

Warnings

For external use only

DOSAGE & ADMINISTRATION

Directions

• ​apply as needed day or night

INACTIVE INGREDIENT

Inactive Ingredients:

Carpylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-30 Cholesterol/Lanosterol Esters, Glycyrrhetinic Acid(from Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol

PRINCIPAL DISPLAY PANEL

CL MD

Sensitive Skin Care

TRUELIPIDS

Truelipids Lip Balm

Net Wt 0.53 Oz (15g)

INGREDIENTS AND APPEARANCE

TRUELIPIDS TRUELIPS LIP BALM  CL MD
white petrolatum solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61387-255
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE NP (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)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61387-255-02	1 in 1 CARTON	11/29/2024
1	NDC: 61387-255-01	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/29/2024

Labeler - Claridei Laboratories, Inc. (035627639)