BIOFREEZE  - menthol gel 
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

Biofreeze



Active Ingredients

Natural Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Uses

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

Warnings:

For external use only.

Flammable:

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

  • Avoid contact with the 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 or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop Use And Ask A Doctor If:

Condition worsens, or of symptoms persist for more than 7 days, or clear up and reoccur.

If pregnant or breastfeeding:

Ask a health professional before use.

Keep out of the reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Other Information:

Store in a cool dry place with lid closed tightly

Questions or Comments?

1-330-633-8460

Representative Labeling

59316-101-50

59316-101-15

59316-101-13

BIOFREEZE  
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59316-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
GLYCERIN 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
CAMPHOR (NATURAL) 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-101-105 mL in 1 PACKET
2NDC:59316-101-1589 mL in 1 BOTTLE, WITH APPLICATOR
3NDC:59316-101-20118 mL in 1 TUBE
4NDC:59316-101-2181 mL in 1 TUBE
5NDC:59316-101-30473 mL in 1 BOTTLE, PUMP
6NDC:59316-101-40946 mL in 1 BOTTLE, PUMP
7NDC:59316-101-503785 mL in 1 BOTTLE, PUMP
8NDC:59316-101-25118 mL in 1 TUBE, WITH APPLICATOR
9NDC:59316-101-1259 mL in 1 TUBE
10NDC:59316-101-1359 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2010
Labeler - Performance Health LLC. (794324061)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(59316-101)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence,LLC825646862manufacture(59316-101)

Revised: 8/2014
Document Id: ff2db7e2-1a25-4e42-9f94-126327b640e4
Set id: 684faf63-5e44-4471-8384-e8fa7c0d842a
Version: 31
Effective Time: 20140807
 
Performance Health LLC.