Label: BIOFREEZE- menthol gel
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NDC Code(s):
59316-101-10,
59316-101-11,
59316-101-12,
59316-101-13, view more59316-101-15, 59316-101-19, 59316-101-20, 59316-101-21, 59316-101-25, 59316-101-30, 59316-101-40, 59316-101-50
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 24, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only.
When Using This Product
- 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
- Directions
- Other Information:
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label
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INGREDIENTS AND APPEARANCE
BIOFREEZE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 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; Type 0: Not a Combination Product 08/25/2016 2 NDC:59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016 3 NDC:59316-101-20 118 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016 4 NDC:59316-101-21 81 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016 12/31/2018 5 NDC:59316-101-30 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016 6 NDC:59316-101-40 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016 7 NDC:59316-101-50 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2016 8 NDC:59316-101-25 118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016 12/31/2021 9 NDC:59316-101-12 59 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2016 10 NDC:59316-101-13 59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/25/2016 11 NDC:59316-101-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2016 12 NDC:59316-101-19 3 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/25/2016 Labeler - RB Health (US) LLC (081049410) Establishment Name Address ID/FEI Business Operations Span Packaging Services dba Multi-Pack Solutions 117101131 manufacture(59316-101) Establishment Name Address ID/FEI Business Operations Span Packaging Services dba Multi-Pack Solutions 557434805 manufacture(59316-101)