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 by

Drug Labeling and Warnings

The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove by is a Otc medication manufactured, distributed, or labeled by The Fresh Market, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

THE FRESH MARKET MEDICATED LIP BALM SOOTHING WITH MENTHOL EUCALYPTUS OIL AND CLOVE 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53040-996
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53040-996-15	4 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/02/2012	12/31/2019

Labeler - The Fresh Market (033041658)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(53040-996)

Revised: 11/2019

Document Id: 982f8f4b-479e-57d8-e053-2995a90adb88

34390-5

Set id: 04cec28c-63b9-49e7-8465-26b0cc7c119f

Version: 4

Effective Time: 20191125