Pain Relief Gel

Pain Relief Gel
SPL v2
SPL
SPL Set ID 9e572c1d-b982-40ac-bc49-bc12a7a5f845
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (6 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Alcohol Ethylhexylglycerin Glycerin Tea Tree Oil Ilex Paraguariensis Leaf Phenoxyethanol Propylene Glycol Trolamine .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-15

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Drug Facts

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces.

Directions
  • Adults and children 12 years of age and older:
  • Apply to affected area not more 4 times a day
  • Massage painful area until absorbed into skin
  • Wash hands after each use with cold water
  • Children under 12 years of age: consult a doctor.
Do Not Use
  • On open wounds, damaged or irritated skin
  • With a heading pad or TENS device
  • With any other creams, ointments, sprays, liniments, or other topical products containing menthol
Active Ingredient

Menthol 6%

Other Information
  • Store away from children
  • Store in dry, well-ventilated conditions at room temperature (59-77°F)
Inactive Ingredients

Aloe barbadensis leaf extract, Arnica montana flower extract, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), water

Questions Or Comments?

J.R WATKINS, LLC

OAKLAND, CA 94612

1-888-384-1945

JRWATKINS.COM

When Using This Product
  • Do not bandage tightly
  • Use only as directed
  • Avoid contact with eyes or mucous membranes
If Pregnant Or Breastfeeding

Ask a health professional before use.

Stop Use and Ask A Doctor If
  • Condition worsens
  • Rash, itching, redness, or excessive irritation of skin develops
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
Principal Display Panel 113 G Tube Label

EXTRA STRENGTH*

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

COOLING

PAIN RELIEF

GEL

WITH NATURAL MENTHOL,

ARNICA & VITAMIN E

FAST-ACTING

MENTHOL PAIN RELIEF

FOR BACKACHES,

SORE MUSCLES,

& JOINT PAIN

USED BY

ATHLETES

NO-MESS APPLICATOR

Net wt. 4.0 oz (113 g)


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Warnings

For external use only.

Flammable:Keep away from fire or flame and heated surfaces.

Directions
  • Adults and children 12 years of age and older:
  • Apply to affected area not more 4 times a day
  • Massage painful area until absorbed into skin
  • Wash hands after each use with cold water
  • Children under 12 years of age: consult a doctor.
Do Not Use (Do not use)
  • On open wounds, damaged or irritated skin
  • With a heading pad or TENS device
  • With any other creams, ointments, sprays, liniments, or other topical products containing menthol
Active Ingredient

Menthol 6%

Other Information (Other information)
  • Store away from children
  • Store in dry, well-ventilated conditions at room temperature (59-77°F)
Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf extract, Arnica montana flower extract, carbomer homopolymer type C (allyl pentaerythritol crosslinked), denatured alcohol, ethylhexylglycerin, glycerin, Melaleuca alternafolia (tea tree) leaf oil, organic Ilex paraguariensis (yerba mate) leaf, phenoxyethanol, propylene glycol, triethanolamine, tocopheryl acetate (vitamin E), water

Questions Or Comments? (Questions or Comments?)

J.R WATKINS, LLC

OAKLAND, CA 94612

1-888-384-1945

JRWATKINS.COM

When Using This Product (When using this product)
  • Do not bandage tightly
  • Use only as directed
  • Avoid contact with eyes or mucous membranes
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
  • Rash, itching, redness, or excessive irritation of skin develops
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
Principal Display Panel 113 G Tube Label (PRINCIPAL DISPLAY PANEL - 113 g Tube Label)

EXTRA STRENGTH*

ESTD 1868

J.R.

WATKINS

REMEDIES FOR BODY™

COOLING

PAIN RELIEF

GEL

WITH NATURAL MENTHOL,

ARNICA & VITAMIN E

FAST-ACTING

MENTHOL PAIN RELIEF

FOR BACKACHES,

SORE MUSCLES,

& JOINT PAIN

USED BY

ATHLETES

NO-MESS APPLICATOR

Net wt. 4.0 oz (113 g)


Advanced Ingredient Data


Raw Label Data

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