Biofreeze Portable Dry Solid

Biofreeze Portable Dry Solid by

Drug Labeling and Warnings

Biofreeze Portable Dry Solid by is a Otc medication manufactured, distributed, or labeled by Performance Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOFREEZE PORTABLE DRY SOLID- menthol stick 
Performance Health LLC

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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Biofreeze Portable Dry Solid

Drug Facts

Active Ingredients

Menthol 10%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis  backache  strains  sprains

Warnings:

For external use only

Ask a doctor before use if you have:

Sensitive skin

When using this product:

Use only as directed Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays, or liniments Do not apply to irritated skin Wash hands after use with cool water Do not bandage or use with heating pad or device Store in a cool dry place away from direct sunlight

Stop use and ask a doctor if:

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

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 immediately

Directions

Adults and Children 12 years of age and older: Turn dial to raise product until a small portion of the stick is showing. Apply by rubbing back and forth to the affected area not more than 4 times daily. Massage not necessary 
Children under 12 years of age: Consult physician

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Coco-caprylate/Caprate, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Isopentyldiol, Wax, Paraffin, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Isostearate, Silica, Sodium Chloride, Sorbitan Isostearate, Water

Questions or Comments:

1-800-246-3733

Package Labeling:59316-879-22

Package Labeling:59316-879-23

BIOFREEZE PORTABLE DRY SOLID 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-879
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-879-22	10 g in 1 CONTAINER; Type 0: Not a Combination Product	01/27/2021	06/05/2021
2	NDC: 59316-879-23	1 in 1 CARTON	01/27/2021	06/05/2021
2		10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/27/2021	06/05/2021

Labeler - Performance Health LLC (794324061)

Revised: 6/2021

Document Id: c440cb3f-71f2-6be8-e053-2995a90afc9b

34390-5

Set id: eb9e1fb8-1430-4b80-a083-64e121c727e4

Version: 2

Effective Time: 20210608