Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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WINCO MEDICATED LIP BALM- petrolatum stick 
Winco

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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Drug Facts

Active ingredient

Petrolatum

Purpose

Skin Protectant

Keep Out of Reach of Children

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

Uses

Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product: avoid contact with eyes. Rinse with water to remove.

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

Directions

Apply liberally and evenly as needed. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Flavor, Cereson, Tocopherol.

Package/Label Principal Display Panel

Winco Medicated Lip Balm Twin Pack
WINCO MEDICATED LIP BALM 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67091-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) 39 mg  in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A) 24 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67091-251-301 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/2015
Labeler - Winco (056098817)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(67091-251) , LABEL(67091-251)

Revised: 1/2015
 
Winco


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