BioFlexor Deep Penetrating Gel

Manufacturer
Health Care Laboratories Inc. | Health Care Laboratories Inc
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:04:49

Label at a glance#

ProductBioFlexor 04
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

Directions Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: consult a doctor

Storage and handling

Store at 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Purpose:

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

Purpose

OTC - PURPOSE SECTION

Topical analgesic

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a doctor

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

STORAGE AND HANDLING SECTION

Store at 15º-30ºC (59º-86ºF)

Do not use

OTC - DO NOT USE SECTION

• on wounds or damaged skin

• with a heating pad

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product:

• avoid contact with the eyes or mucous membranes

• do not bandage tightly

OTC - STOP USE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioflexor

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1304408BioFlexor 3 % Topical GelPSN14
259150menthol 3 % Topical GelPSN14
1304408menthol 0.03 MG/MG Topical Gel [Bioflexor]SBD14
259150menthol 0.03 MG/MG Topical GelSCD14
1304408Bioflexor 0.03 MG/MG Topical GelSY14
1304408Bioflexor 3 % Topical GelSY14
259150menthol 3 % Topical GelSY14

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62391-100-022024-07-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042024-07-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302024-07-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022024-01-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042024-01-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302024-01-30C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022023-12-18C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042023-12-18C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302023-12-18C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022023-07-28C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042023-07-28C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302023-07-28C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022022-12-06C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042022-12-06C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302022-12-06C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022022-07-29C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042022-07-29C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302022-07-29C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022021-11-12C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042021-11-12C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302021-11-12C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-022021-07-23C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-042021-07-23C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel
62391-100-302021-07-23C16284748780-1c7ccaba7-1215-fd44-e053-dadaa90aa01bBioFlexor Deep Penetrating Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62391-100-02BioFlexor0467.5 g in 1 JARGEL67.514
62391-100-04BioFlexor04135 g in 1 JARGEL13514
62391-100-30BioFlexor04960 g in 1 JARGEL96014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62391-100BIOFLEXOR 04 (MENTHOL) GEL [HEALTH CARE LABORATORIES INC.]14Legacy NDC, 3 package rows20231219_7f49ad9a-4062-69ee-e053-2a91aa0a6bd5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62391-10062391-100-04, 62391-100-02, 62391-100-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c51dfc1-f8ba-2a95-e063-6294a90ad78f7f49ad9a-4062-69ee-e053-2a91aa0a6bd52023-12-12WarningsExact identifier
spl id: 0c51dfc1-f8ba-2a95-e063-6294a90ad78f
spl set id: 7f49ad9a-4062-69ee-e053-2a91aa0a6bd5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.