Biofreeze Pain Relieving Gel

SPL v42

SPL

SPL Set ID 684faf63-5e44-4471-8384-e8fa7c0d842a

Route

TOPICAL

Published

Effective Date 2022-02-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (35 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Yellow No. 5 Glycerin Isopropyl Alcohol Methylparaben Camphor (natural) Propylene Glycol Silicon Dioxide Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-08-25 Until 2021-12-31

Description

Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Medication Information

Purpose

Cooling Pain Reliever

Description

Menthol USP 3.5%

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

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

Active Ingredients

Menthol USP 3.5%

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients

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 USP

Questions Or Comments?

800-246-3733

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

If Pregnant Or Breastfeeding:

Ask a health professional before use.

Stop Use and Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Keep Out of the Reach of Children:

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

Ask A Doctor Before Use If You Have:

sensitive skin

Principal Display Panel 473 Ml Bottle Pump Label

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING gel

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

16 fl oz / 473 mL

Principal Display Panel 89 Ml Bottle Applicator Label

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING Roll-On

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

3 fl oz / 89 mL

Structured Label Content

Uses

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

Purpose

Cooling Pain Reliever

Warnings

For external use only.

Flammable

Keep away from excessive heat or open flame

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

Active Ingredients

Menthol USP 3.5%

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients (Inactive ingredients)

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 USP

Questions Or Comments? (Questions or Comments?)

800-246-3733

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

If Pregnant Or Breastfeeding: (If pregnant or breastfeeding:)

Ask a health professional before use.

Stop Use and Ask A Doctor If: (Stop Use And Ask A Doctor If:)

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

Keep Out of the Reach of Children: (Keep out of the reach of children:)

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

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

sensitive skin

Principal Display Panel 473 Ml Bottle Pump Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label)

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING gel

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

16 fl oz / 473 mL

Principal Display Panel 89 Ml Bottle Applicator Label (PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label)

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING Roll-On

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

3 fl oz / 89 mL

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "35", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain", "Purpose": "Cooling Pain Reliever", "Warnings": "For external use only.", "Flammable": "Keep away from excessive heat or open flame", "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", "Active Ingredients": "Menthol USP 3.5%", "Other Information:": "Store in a cool dry place with lid closed tightly", "Inactive ingredients": "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 USP", "Questions or Comments?": "800-246-3733", "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", "If pregnant or breastfeeding:": "Ask a health professional before use.", "Stop Use And Ask A Doctor If:": "Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.", "Keep out of the reach of children:": "If accidentally ingested, get medical help or contact a Poison Control Center immediately.", "Ask a doctor before use if you have:": "sensitive skin", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label": "PENETRATING, LONG LASTING PAIN RELIEF FROM: ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN BIOFREEZE ® PAIN RELIEVING gel WITH SOOTHING MENTHOL Cryotherapy - The Cold Method ® 16 fl oz / 473 mL", "PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label": "PENETRATING, LONG LASTING PAIN RELIEF FROM: ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN BIOFREEZE ® PAIN RELIEVING Roll-On WITH SOOTHING MENTHOL Cryotherapy - The Cold Method ® 3 fl oz / 89 mL"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.370035 · Updated: 2026-03-14T23:06:23.767952