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
ORALABS CHAPICE CHERRY PETROLATUM 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63645-170-061 g in 1 CONTAINER; Type 0: Not a Combination Product03/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/09/2020
Labeler - OraLabs (801824756)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(63645-170) , LABEL(63645-170)

Revised: 3/2020
Document Id: 7e1509c1-6d7b-4984-ac5f-75029ea9bab6
Set id: f0d9d01e-bfdf-4e33-abfb-f683d414d808
Version: 1
Effective Time: 20200309
 
OraLabs