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NDC 59316-0001-10 Biofreeze Foot Cream 100 mg/g Details

Biofreeze Foot Cream 100 mg/g

Biofreeze Foot Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	59316-0001
Product ID	59316-001_57c77fac-ce39-41ee-9578-6977826d908d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Biofreeze Foot Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59316-0001-10 (59316000110)

Pricing Information	N/A
NDC Package Code	59316-001-10
Billing NDC	59316000110
Package	85 g in 1 TUBE (59316-001-10)
Marketing Start Date	2021-03-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 32450cbf-4ed4-402b-a30e-e08a17bba3fb Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 10%

Purpose

Pain Relieving Cream

Uses

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

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only.

When using this product

use only as directed
avoid contact with the eyes or on mucous membranes
do not apply to wounds or damaged skin
do not apply to irritated skin or if excessive irritation develops
do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

you experience pain, swelling or blistering of the skin
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
arthritic pain persists for more than 10 days, or redness is present

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

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

Directions

adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
children under 12 years of age: consult a physician
wash hands after use with cool water

Other information

store at 20-25°C (68-77°F)
store in a cool dry place away from direct sunlight

Inactive ingredients

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Questions or comments?

1-800-246-3733

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label

CLINICALLY

RECOMMENDED*

NDC 59316-001-20

BiOFREEZE®

COOL THE PAIN

FOOT CREAM

MENTHOL-PAIN

RELIEVING CREAM

Net wt 4 OZ (113.3 g)

PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label

INGREDIENTS AND APPEARANCE

BIOFREEZE FOOT CREAM

menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59316-001-10	85 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2021
2	NDC:59316-001-20	113.3 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/12/2021

Labeler - RB Health (US) LLC (081049410)

Revised: 1/2022

Document Id: 57c77fac-ce39-41ee-9578-6977826d908d

Set id: 32450cbf-4ed4-402b-a30e-e08a17bba3fb

Version: 3

Effective Time: 20220118

Search by Drug Name or NDC

NDC 59316-0001-10 Biofreeze Foot Cream 100 mg/g Details

Biofreeze Foot Cream 100 mg/g

Product Information

Package

Package Images

NDC 59316-0001-10 (59316000110)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 32450cbf-4ed4-402b-a30e-e08a17bba3fb Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 113.3 g Tube Label

INGREDIENTS AND APPEARANCE

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