Biofreeze Overnight Gel

Biofreeze Overnight Gel
SPL v2
SPL
SPL Set ID f5c8c08b-c7c0-f84d-e053-2a95a90add15
Route
TOPICAL
Published
Effective Date 2023-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Arctium Lappa Root .alpha.-tocopherol Acetate Water Trolamine Frankincense Arnica Montana Flower Calendula Officinalis Flower Green Tea Leaf Alcohol Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Melissa Officinalis Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01
Description

For external use only Flammable: Keep away from excessive heat or open flame When using this product: • Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device •Children 2 years to under 12 years of age:Use only under adult supervision Stop use and ask a doctor if: You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away

Medication Information

Description

For external use only Flammable: Keep away from excessive heat or open flame When using this product: • Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device •Children 2 years to under 12 years of age:Use only under adult supervision Stop use and ask a doctor if: You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away

Uses

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Active

Active ingredient

Menthol 4% Purpose-Pain Relieving Gel

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51945-4

NDC 59316-121-10

BiOFREEZE®

GEL

MENTHOL-PAIN

RELIEVING GEL

3 FL OZ 89 mL

Section 53413-1

Questions or comments? 1-800-246-3733

Section 55105-1

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

When using this product:

• Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device •Children 2 years to under 12 years of age:Use only under adult supervision

Stop use and ask a doctor if:

You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breastfeeding:

Ask a health professional before use

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions

¢ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily

¢ children under 2 years of age: consult a physician

¢ wash hands after use with cool water

Drug Facts

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Other Info

Other information

¢ store at 20-25°C (68-77°F)

¢ store in a cool dry place away from direct sunlight

Inactive Ingredients

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Structured Label Content

Uses

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Active

Active ingredient

Menthol 4% Purpose-Pain Relieving Gel

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51945-4 (51945-4)

NDC 59316-121-10

BiOFREEZE®

GEL

MENTHOL-PAIN

RELIEVING GEL

3 FL OZ 89 mL

Section 53413-1 (53413-1)

Questions or comments? 1-800-246-3733

Section 55105-1 (55105-1)

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

When using this product:

• Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device •Children 2 years to under 12 years of age:Use only under adult supervision

Stop use and ask a doctor if:

You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breastfeeding:

Ask a health professional before use

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions

¢ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily

¢ children under 2 years of age: consult a physician

¢ wash hands after use with cool water

Drug Facts

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Other Info

Other information

¢ store at 20-25°C (68-77°F)

¢ store in a cool dry place away from direct sunlight

Inactive Ingredients

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.901565 · Updated: 2026-03-14T23:06:27.679265