LEADER LIP TREATMENT- petrolatum gel

Leader Lip Treatment by

Drug Labeling and Warnings

Leader Lip Treatment 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, 100%

Purpose

Skin Protectant

Keep Out of Reach of Children

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

Uses

Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

Warnings

For external use only. When using this product –Do not get into eyes. Stop use and ask a doctor if – condition worsens-symptoms last more than 7 days or clear up and occur again within a few days.

Directions

Apply as needed.

Inactive Ingredients

Flavor

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LEADER LIP TREATMENT 
petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.98 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)	0.02 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: 49781-111-35	1 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/02/2013

Labeler - Cardinal Health (Leader) (097537435)

Registrant - Cardinal Health (Leader) (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(49781-111) , LABEL(49781-111)