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NDC 59316-0002-10 Biofreeze Foot Pain Relief Set Details

Biofreeze Foot Pain Relief Set

Biofreeze Foot Pain Relief Set is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is .

Product Information

NDC	59316-0002
Product ID	59316-002_b3a7c30b-7927-46ab-81ae-9fc25ecda859
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 Pain Relief Set
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
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 59316-0002-10 (59316000210)

Pricing Information	N/A
NDC Package Code	59316-002-10
Billing NDC	59316000210
Package	1 KIT in 1 KIT (59316-002-10) * 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 4a885eef-0364-4655-bccc-7158c76cc5b2 Details

Drug Facts

Active ingredient:

Menthol 10%

Purpose

Pain Relieving Cream

Uses:

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

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 breastfeeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, 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 areas not more than 3 to 4 times daily;

• Children under 12 years of age: Consult a physician

• wash hands after use with cool water

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Kit

NDC 59316-002-10

BiOFREEZE®

COOL THE PAIN

FOOT PAIN

RELIEF SET

MENTHOL-PAIN

RELIEVING CREAM

FOOT ROLLER intended to

relieve foot pain and pain associated

with plantar fasciitis

1 Biofreeze Foot Cream Tube

Net wt 3 OZ (85 g)

+ 1 Foot Roller

INGREDIENTS AND APPEARANCE

BIOFREEZE FOOT PAIN RELIEF SET

menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-002

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-002-10	1 in 1 KIT	03/12/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	85 g

Part 1 of 1
BIOFREEZE FOOT CREAM menthol cream

Product Information
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	Marketing End Date
Packaging
1	NDC:59316-001-10	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	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: 2/2022

Document Id: b3a7c30b-7927-46ab-81ae-9fc25ecda859

Set id: 4a885eef-0364-4655-bccc-7158c76cc5b2

Version: 4

Effective Time: 20220223