LEADER MEDICATED LIP BALM- petrolatum stick

Leader Medicated Lip Balm by

Drug Labeling and Warnings

Leader Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader), OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Petrolatum

Purpose

Skin Protectant

Keep Out of Reach of Children

If swallowed, contact a Poison Control Center.

Uses

Helps prevent and temporarily protects chapped or wind burned lips.

Warnings

For external use only. When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if: rash or irritation develops and lasts for more than 7 days.

Directions

Apply liberally and evenly as needed. Reapply as needed. Children under 2 years of age; ask a doctor before use.

Inactive Ingredients

Beeswax, Camphor, Cetyl Alcohol, Flavor, Isopropyl Myristate, Lanolin, Menthol, Methylparaben, Mineral Oil, Octyldodecanol, Oleyl Alcohol, Ozokerite, Phenol, Phenyl Trimethicone, Propylparaben, Stearyl Alcohol, Water.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LEADER MEDICATED LIP BALM 
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)	16 mg  in 1 g
YELLOW WAX (UNII: 2ZA36H0S2V)	6 mg  in 1 g
OLEYL ALCOHOL (UNII: 172F2WN8DV)	6 mg  in 1 g
OCTYLDODECANOL (UNII: 461N1O614Y)	9 mg  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	5 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H)	4 mg  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	3 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	3 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)	1 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A)	.6 mg  in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-112-35	1 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2013

Labeler - Cardinal Health (Leader) (097537435)

Registrant - Cardinal Health (Leader) (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(49781-112) , LABEL(49781-112)