Biofreeze Pain Relieving Spray

Drug Facts

Composition & Product

Active Ingredients

Menthol, Unspecified Form (100 mg)

Inactive Ingredients

Arnica Montana Whole Calendula Officinalis Flower Chamomile Dimethyl Sulfoxide Echinacea, Unspecified Alcohol Ilex Paraguariensis Leaf Isopropyl Myristate Juniperus Communis Whole Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-11-01 Until 2018-12-31

Medication Information

Purpose

Cooling Pain Reliever

Description

Menthol USP 10%

Uses:

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

Section 42229-5

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Directions

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary.

Children under 12 years of age:Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol, ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea

Questions Or Comments?

1-800-246-3733

When Using This Product:

-Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages 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 reoccur

Keep Out of 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 Label

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING Spray

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

16 fl. oz./473mL

Structured Label Content

Uses:

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

Section 42229-5 (42229-5)

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Purpose

Cooling Pain Reliever

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Directions

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary.

Children under 12 years of age:Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol, ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea

Questions Or Comments? (Questions or Comments?)

1-800-246-3733

When Using This Product:

-Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages 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 reoccur

Keep Out of Reach of Children: (Keep out of 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 Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®

PAIN RELIEVING Spray

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

16 fl. oz./473mL

Advanced Ingredient Data

[{"name": "ARNICA MONTANA WHOLE", "unii": "O80TY208ZW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHYL SULFOXIDE", "unii": "YOW8V9698H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ECHINACEA, UNSPECIFIED", "unii": "4N9P6CC1DX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ILEX PARAGUARIENSIS LEAF", "unii": "1Q953B4O4F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JUNIPERUS COMMUNIS WHOLE", "unii": "464910T5N9", "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": "100", "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 - sprains", "42229-5": "Dist. by: RB Health (US), Parsippany, NJ 07054-0224", "Purpose": "Cooling Pain Reliever", "Warnings:": "For external use only Flammable: Keep away from excessive heat or open flame", "Directions": "Adults and children 12 years of age and older: Spray on to the affected areas not more than 4 times daily; massage not necessary. Children under 12 years of age: Consult a physician", "Other Information:": "Store in a cool dry place with lid closed tightly", "Active Ingredients:": "Menthol USP 10%", "Inactive Ingredients:": "Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol, ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea", "Questions or Comments?": "1-800-246-3733", "When Using This Product:": "-Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages 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 reoccur", "Keep out of 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 Label": "PENETRATING, LONG LASTING PAIN RELIEF FROM: ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN BIOFREEZE ® PAIN RELIEVING Spray WITH SOOTHING MENTHOL Cryotherapy - The Cold Method ® 16 fl. oz./473mL"}

Biofreeze Pain Relieving Spray

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information