ABEJAS Y VIBORAS BRAND ROLL-ON- menthol gel 
MENPER DISTRIBUTORS INC.

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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Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Warnings

For external use only

Do not use

Ask a doctor before use if you have redness over the affected area.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health profiessional before use.

Keep out of reach of children to avoid accidental poisoning. If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Directions

Inactive ingredients Camphor, carbomer 940, D&C yellow #10, FD&C yellow #5, glycerin, isopropyl myristate, methyl salicylate, methylchloroisothiazolinone, methlylisothiazolinone, polysorbate 20, propylene glycol, triethanolamine, water.

Questions? Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

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ABEJAS Y VIBORAS BRAND ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-703
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-703-031 in 1 CARTON03/01/2021
188 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2021
Labeler - MENPER DISTRIBUTORS INC. (101947166)

Revised: 3/2021
Document Id: 8515d6ec-4cb3-4394-94ae-c27ec6a84c38
Set id: 17cd35f6-e0d3-4875-9ca6-1d47d352d7d3
Version: 5
Effective Time: 20210301
 
MENPER DISTRIBUTORS INC.