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Maybelline New York Baby Lips Dr Rescue Medicated Balm

Medically reviewed on September 12, 2017

Dosage form: lipstick
Ingredients: MENTHOL 5mg in 1g
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-489

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

Menthol 0.5%

Purpose

External analgesic

Use

for the temporary relief of pain associated with fever blisters and cold sores

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

for adult use only: apply to affected area not more than 3 to 4 times daily

Inactive ingredients

octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract

Questions or comments?

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

MAYBELLINE NEW YORK BABY LIPS DR RESCUE MEDICATED BALM 
menthol lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-489
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:49967-489-011 TUBE in 1 BLISTER PACK
14.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2013
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
L'Oreal USA, Inc.624244349manufacture(49967-489)

 
L'Oreal USA Products Inc

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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