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Care One Medicated Lip Balm in a Pot

Medically reviewed on March 12, 2018.

Dosage form: ointment
Ingredients: PETROLATUM 43.75mg in 1g
Labeler: American Sales Company
NDC Code: 41520-976

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

Purpose

Skin Protectant

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting a Poison Control Center.

Uses

Helps prevent and temporarily protect dry and chapped lips.

Warnings

For external use only: When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age.

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor

Package/Label Principal Display Panel
CARE ONE MEDICATED LIP BALM IN A POT 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-976
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM43.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX15.65 mg  in 1 g
MINERAL OIL15.5 mg  in 1 g
MICROCRYSTALLINE WAX12 mg  in 1 g
LANOLIN8 mg  in 1 g
3-BROMOCAMPHOR, (+/-)-1.7 mg  in 1 g
CARNAUBA WAX.85 mg  in 1 g
COCOA BUTTER.70 mg  in 1 g
MENTHOL.70 mg  in 1 g
2-BUTANOYLOXYBENZOIC ACID.5 mg  in 1 g
PHENOL0.4 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-976-031 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/12/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
NameAddressID/FEIOperations
OraLabs801824756MANUFACTURE(41520-976), LABEL(41520-976)

 
American Sales Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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