Top Care 894.002/894ab

Top Care 894.002/894ab
SPL v26
SPL
SPL Set ID 80962394-a46f-48fd-8e0c-685dd1e500d7
Route
TOPICAL
Published
Effective Date 2025-06-11
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 Arnica Montana Flower Fd&c Blue No. 1 Frankincense Calendula Officinalis Flower Green Tea Leaf Camphor (natural) Carbomer Homopolymer, Unspecified Type Chamomile Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Juniper Berry Melissa Officinalis Whole Silicon Dioxide .alpha.-tocopherol Acetate Trolamine Water Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-24

Description

Menthol 4%

Purpose

External analgesic

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143      ©TOPCO VIJA 0524 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED


Medication Information

Purpose

External analgesic

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143      ©TOPCO VIJA 0524 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED

Description

Menthol 4%

Use

for temporary relief from minor aches and pains of muscles & joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Warnings

For external use only

Flammable, keep away from fire or flame.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Disclaimer

*This products is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze ® Gel Menthol Pain Relief.

Active Ingredient

Menthol 4%

Other Information
  • store in a cool dry place with lid closed tightly
Inactive Ingredients

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

Questions Or Comments?

1-888-423-0139

Principal Display Panel

NDC 76162-894-21

TopCare ® health

COMPARE TO BIOFREEZE ®GEL MENTHOL PAIN RELIEF*

Cooling Therapy Pain Relief

Pain Relieving Gel

with Menthol 4%

  • For Arthritis, Back Pain, Sore Muscles & Joints
  • Disappearing Scent
  • Fast Acting Menthol Pain Relief
  • Paraben-Free

3 FL OZ (89 mL)

When Using This Product
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Adverse Reactions Section

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143      ©TOPCO VIJA 0524

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

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


Structured Label Content

Use

for temporary relief from minor aches and pains of muscles & joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

External analgesic

Warnings

For external use only

Flammable, keep away from fire or flame.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Disclaimer

*This products is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze ® Gel Menthol Pain Relief.

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)
  • store in a cool dry place with lid closed tightly
Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (Principal display panel)

NDC 76162-894-21

TopCare ® health

COMPARE TO BIOFREEZE ®GEL MENTHOL PAIN RELIEF*

Cooling Therapy Pain Relief

Pain Relieving Gel

with Menthol 4%

  • For Arthritis, Back Pain, Sore Muscles & Joints
  • Disappearing Scent
  • Fast Acting Menthol Pain Relief
  • Paraben-Free

3 FL OZ (89 mL)

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Adverse Reactions Section

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143      ©TOPCO VIJA 0524

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

QUALITY GUARANTEED

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 occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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