WINCO MEDICATED LIP BALM- petrolatum stick

Winco Medicated Lip Balm by

Drug Labeling and Warnings

Winco Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Winco, OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

WINCO MEDICATED LIP BALM 
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-251-30	1 g in 1 CONTAINER; Type 0: Not a Combination Product	01/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/02/2015

Labeler - Winco (056098817)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(67091-251) , LABEL(67091-251)