pain relieving cooling gel

pain relieving cooling gel
SPL v4
SPL
SPL Set ID 3574d48a-b546-4ea7-b470-071bb328de64
Route
topical
Published
Effective Date 2023-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (3 g)
Inactive Ingredients
alcohol water tromethamine polysorbate 60 carbomer interpolymer type a (allyl sucrose crosslinked)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-09-01

Purpose

EXTERNAL ANALGESIC

Description

Drug Facts


Medication Information

Warnings

For external use only.

Flammable:Keep away from fire or flame.

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

EXTERNAL ANALGESIC

Directions
  • Use only as directed
  • Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.
  • Wash hands carefully after using
Other Information
  • do not use if tamper evident seal is not intact
  • store away from children
  • store in dry, well-ventilated conditions at room temperature (59-77°F)
Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

Description

Drug Facts

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.

Do Not Use
  • on wounds or damaged skin
  • with a heading pad
Active Ingredient

MENTHOL 3%

Questions Or Comments?

1-888-384-1945

When Using This Product
  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash or irritation occurs
Principal Display Panel 93 G Tube Label

TRUSTED REMEDIES

SINCE 1868

ESTD

1868

J.R.

WATKINS

REMEDIES FOR BODY ®

PAIN RELIEVING

COOLING

GEL

WITH

NATURAL

MENTHOL

TEMPORARY

RELIEF FOR

MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)


Structured Label Content

Warnings

For external use only.

Flammable:Keep away from fire or flame.

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

EXTERNAL ANALGESIC

Directions
  • Use only as directed
  • Adults and children 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.
  • Wash hands carefully after using
Other Information (Other information)
  • do not use if tamper evident seal is not intact
  • store away from children
  • store in dry, well-ventilated conditions at room temperature (59-77°F)
Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water

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.

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heading pad
Active Ingredient

MENTHOL 3%

Questions Or Comments? (Questions or Comments?)

1-888-384-1945

When Using This Product (When using this product)
  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash or irritation occurs
Principal Display Panel 93 G Tube Label (PRINCIPAL DISPLAY PANEL - 93 g Tube Label)

TRUSTED REMEDIES

SINCE 1868

ESTD

1868

J.R.

WATKINS

REMEDIES FOR BODY ®

PAIN RELIEVING

COOLING

GEL

WITH

NATURAL

MENTHOL

TEMPORARY

RELIEF FOR

MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)


Advanced Ingredient Data


Raw Label Data

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