Biofreeze Pain Relieving Gel

Biofreeze Pain Relieving Gel

Drug Labeling and Warnings

Drug Details

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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 Pain Relieving Gel

Active Ingredients

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

  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
  • Children under 2 years of age : Consult physician

Other Information:

Store in a cool dry place with lid closed tightly

  • carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U

Questions or Comments?

1-330-633-8460

BIOFREEZE - menthol gel (59316-101-10)

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BIOFREEZE - menthol gel (59316-101-11)

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BIOFREEZE - menthol gel (59316-101-13)

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BIOFREEZE - menthol gel (59316-101-12)

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BIOFREEZE - menthol gel (59316-101-15)

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BIOFREEZE - menthol gel (59316-101-20)

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BIOFREEZE - menthol gel (59316-101-30)

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BIOFREEZE - menthol gel (59316-101-50)

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BIOFREEZE - menthol gel (59316-101-40)

946mL-32 oz label-pain reliever gel

BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-101-105 mL in 1 PACKET; Type 0: Not a Combination Product08/25/2016
2NDC: 59316-101-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
3NDC: 59316-101-20118 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
4NDC: 59316-101-2181 mL in 1 TUBE; Type 0: Not a Combination Product08/25/201612/31/2018
5NDC: 59316-101-30473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
6NDC: 59316-101-40946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
7NDC: 59316-101-503785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
8NDC: 59316-101-25118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
9NDC: 59316-101-1259 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
10NDC: 59316-101-1359 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
11NDC: 59316-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/25/2016
Labeler - Performance Health LLC. (794324061)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services dba Multi-Pack Solutions557434805manufacture(59316-101)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence,LLC825646862manufacture(59316-101)

Revised: 9/2019
 
Performance Health LLC.


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