Swan 894.001/894aa Rev 1

Swan 894.001/894aa Rev 1
SPL v3
SPL
SPL Set ID 696f678d-8f76-4087-a52e-efe3c9f814d0
Route
TOPICAL
Published
Effective Date 2025-04-03
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 Sodium Hydroxide .alpha.-tocopherol Acetate Water Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-13

Description

Menthol 4%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 4%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 51727-6

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

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 product is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieving Gel.

Adverse Reaction

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient

Menthol 4%

Other Information

store in a cool dry place with lid closed tightly

Principal Display Panel

swan ®

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

  • For arthritis, sore muscles, joints and back pain
  • Diminishing scent

Compare to Biofreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieveing Gel*

2.5 FL OZ (74 mL)

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

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 51727-6 (51727-6)

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

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 product is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieving Gel.

Adverse Reaction (Adverse reaction)

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Active Ingredient (Active ingredient)

Menthol 4%

Other Information (Other information)

store in a cool dry place with lid closed tightly

Principal Display Panel (Principal display panel)

swan ®

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

  • For arthritis, sore muscles, joints and back pain
  • Diminishing scent

Compare to Biofreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieveing Gel*

2.5 FL OZ (74 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
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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