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 Type HUMAN OTC DRUG Item Code (Source) NDC:59316-101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 35 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-101-10 5 mL in 1 PACKET
2 NDC:59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR
3 NDC:59316-101-20 118 mL in 1 TUBE
4 NDC:59316-101-21 81 mL in 1 TUBE
5 NDC:59316-101-30 473 mL in 1 BOTTLE, PUMP
6 NDC:59316-101-40 946 mL in 1 BOTTLE, PUMP
7 NDC:59316-101-50 3785 mL in 1 BOTTLE, PUMP
8 NDC:59316-101-25 118 mL in 1 TUBE, WITH APPLICATOR
9 NDC:59316-101-12 59 mL in 1 TUBE
10 NDC:59316-101-13 59 mL in 1 BOTTLE, WITH APPLICATOR
11 NDC:59316-101-11 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/03/2010
Labeler - Performance Health LLC. (794324061)
Establishment
Name Address ID/FEI Business Operations
Span Packaging Services LLC 557434805 manufacture(59316-101)
Establishment
Name Address ID/FEI Business Operations
Cosmetic Essence,LLC 825646862 manufacture(59316-101)

Revised: 10/2014
Document Id: f9cd7654-60ec-4107-9aca-86a8ba3ff701
Set id: 684faf63-5e44-4471-8384-e8fa7c0d842a
Version: 32
Effective Time: 20141020
 
Performance Health LLC.