BIOFLEXOR 04- menthol gel 
Health Care Laboratories Inc.

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BioFlexor Deep Penetrating Gel

ACTIVE INGREDIENT

Active Ingredient: Purpose:

Menthol 3% ……………………………………………………………………Topical Analgesic

Purpose

Topical analgesic

INACTIVE INGREDIENTS

Inactive Ingredients: Aloe Vera Juice, Butyl Paraben, Camphor USP, Carbopol Polymer, Edetate Disodium, Ethyl Paraben, Eucalyptus Oil, Isobutyl Paraben, Methyl Paraben, Peacock Blue MX26, 2-Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Propyl Paraben, Purified Water, Sodium Hydroxide, Yerba Mate, Yucca

WARNINGS SECTION

For external use only.

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

Dosage and Administration

Directions

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

Store at 15º-30ºC (59º-86ºF)

Do not use

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

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

When using this product:

• avoid contact with the eyes or mucous membranes

• do not bandage tightly

Stop use and ask a doctor if:

• condition worsens or symptoms persist for more than 7 days

• symptoms clear up and occur again within a few days

• excessive skin irritation occurs

PRINCIPAL DISPLAY PANEL

Bioflexor

Front Panel

BIOFLEXOR  04
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62391-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Product Characteristics
ColorturquoiseScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62391-100-04135 g in 1 JAR; Type 0: Not a Combination Product03/01/1998
2NDC:62391-100-0267.5 g in 1 JAR; Type 0: Not a Combination Product03/01/1998
3NDC:62391-100-30960 g in 1 JAR; Type 0: Not a Combination Product03/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/01/1998
Labeler - Health Care Laboratories Inc. (088637298)
Registrant - Health Care Laboratories Inc (088637298)
Establishment
NameAddressID/FEIBusiness Operations
Health Care Laboratories Inc.088637298manufacture(62391-100)

Revised: 12/2023
Document Id: 0c51dfc1-f8ba-2a95-e063-6294a90ad78f
Set id: 7f49ad9a-4062-69ee-e053-2a91aa0a6bd5
Version: 14
Effective Time: 20231212
 
Health Care Laboratories Inc.