The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove

The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove

Drug Labeling and Warnings

Drug Details

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THE FRESH MARKET MEDICATED LIP BALM SOOTHING WITH MENTHOL EUCALYPTUS OIL AND CLOVE- menthol stick 
The Fresh Market

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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The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove

Drug Facts


Active Ingredients:

Menthol 0.6%

Purpose

External Analgesic

Uses:

For the temporary relief of pain and itching associated with fever blisters and cold sores.

Warnings:

For external use only.

Avoid contact with eyes

if this happens, rinse thoroughly with water. If condition worsens or if symptoms persist for more than 7 days or clear up and occur again with in a few days, discontinue use and consult a doctor.

Keep out of reach of children


Directions:

Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily. Children under 2 years of age: consult a doctor.

Inactive Ingredients:

cera alba (beeswax), camphor, cocos nucifera (coconut) oil, eucalyptus globulus leaf oil, helianthus annuus (sunflower) seed oil, lanolin, persea gratissima (avocado) oil, simmondsia chinensis (jojoba) seed oil, syzygium aromaticum (clove bud) oil, tocopherol (vitamin e), vitis vinifera (grapeseed).

Questions?

Call 866-817-4367

Distributed by:

The Fresh Market Greensborb, NC 27408 (866) 817-4367 www.thefreshmarket.com Made in USA 737094204594

THE FRESH MARKET MEDICATED LIP BALM SOOTHING WITH MENTHOL EUCALYPTUS OIL AND CLOVE net wt. 0.15 oz(4g)

Product Label

Medicated Lip Balm

THE FRESH MARKET MEDICATED LIP BALM SOOTHING WITH MENTHOL EUCALYPTUS OIL AND CLOVE 
menthol stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53040-996
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LANOLIN (UNII: 7EV65EAW6H)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53040-996-154 g in 1 TUBE; Type 0: Not a Combination Product08/02/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/02/2012
Labeler - The Fresh Market (033041658)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(53040-996)

Revised: 1/2019
 
The Fresh Market


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