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Leader Lip Treatment

Medically reviewed on Apr 16, 2018

Dosage form: gel
Ingredients: PETROLATUM 99.98mg in 1g
Labeler: Cardinal Health (Leader)
NDC Code: 49781-111

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.

Drug Facts

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

LEADER LIP TREATMENT 
petrolatum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM99.98 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE0.02 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-111-351 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/02/2013
Labeler - Cardinal Health (Leader) (097537435)
Registrant - Cardinal Health (Leader) (097537435)
Establishment
NameAddressID/FEIOperations
OraLabs801824756MANUFACTURE(49781-111), LABEL(49781-111)

 
Cardinal Health (Leader)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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