EASE YOUR PAIN- menthol cream 
Proximity Capital Partners LLC dba Asutra

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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Menthol USP 4%

Menthol USP 4% ........................... Topical Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with

Use only as directed.

For external use only. Keep away from excessive heat or flame.

When using this product:

  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breastfeeding: Ask a health professional before using.

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

Adults and children 2 years of age and older:

Children under 2 years of age:

Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

001

EASE YOUR PAIN 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALCOHOL (UNII: 3K9958V90M)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72683-002-011 in 1 CARTON01/21/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/21/2019
Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(72683-002)

Revised: 12/2020
Document Id: b5eb8560-647f-f1f3-e053-2995a90a8781
Set id: 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4
Version: 2
Effective Time: 20201207
 
Proximity Capital Partners LLC dba Asutra