TOPICAL EDGE- menthol lotion 
AmperSand Biopharma

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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Topical Edge Label

TOPICAL EDGE 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70458-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
SORBIC ACID (UNII: X045WJ989B)  
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)  
POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PALM KERNEL OIL (UNII: B0S90M0233)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70458-500-02300 g in 1 TUBE; Type 0: Not a Combination Product09/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/25/2017
Labeler - AmperSand Biopharma (080111681)

Revised: 8/2017
Document Id: 5815d5b2-5fc0-780a-e053-2a91aa0ae946
Set id: 5815d5b2-5fbf-780a-e053-2a91aa0ae946
Version: 1
Effective Time: 20170831
 
AmperSand Biopharma