biofreeze pain relieving gel

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
Purpose

Cooling Pain Reliever

Description

Menthol USP 3.5%

Medication Information

Warnings

For external use only.

Uses

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

Purpose

Cooling Pain Reliever

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
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
Description

Menthol USP 3.5%

Flammable

Keep away from excessive heat or open flame

Active Ingredients

Menthol USP 3.5%

Other Information:

Store in a cool dry place with lid closed tightly

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

Warnings

For external use only.

Uses

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

Purpose

Cooling Pain Reliever

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
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
Flammable

Keep away from excessive heat or open flame

Active Ingredients

Menthol USP 3.5%

Other Information:

Store in a cool dry place with lid closed tightly

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

Raw Label Data

All Sections (JSON)

Additional Information

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