ORALABS CHAPICE CHERRY PETROLATUM- petrolatum stick
OraLabs

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, 45%

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 protect dry, chapped or windburned lips.

Warnings

For external use only. Stop use and ask a doctor if rash or irritation develops and lasts. Children under 6 months of age: Ask a doctor before use.

Directions

Apply as needed.

Inactive Ingredients

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).

Package/Label Principal Display Panel

ORALABS CHAPICE CHERRY PETROLATUM
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-170
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	45 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)	28 ug in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	17.5 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	3.0 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	1.0 mg in 1 g

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-170-06	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/09/2020

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-170) , LABEL(63645-170)