483 - Cold Therapy Roll On

483 - Cold Therapy Roll On
SPL v2
SPL
SPL Set ID 36463acb-7c28-416f-a45f-a93f0be5692b
Route
TOPICAL
Published
Effective Date 2025-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (.04 g)
Inactive Ingredients
Blue 1 Carbomer Isopropyl Alcohol Magnesium Sulfate Sodium Hydroxide Water Yellow 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-29

Description

Menthol 4%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Menthol 4%

Use(s)

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

Directions

Shake well before each use.

Adults and children over 2 years:

• rub a thin film over affected area not more than 3 to 4 times daily

• wash hands after use with cool water

children under 2 years of age: ask a doctor

Other Information

Store at 15ºC - 30ºC (59ºF - 86ºF).

Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Menthol 4%

Inactive Ingredients

blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5

Principal Display Panel
Roll on Gel
When Using This Product

• use only as directed

• avoid contact with 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 symptoms persist for more then 7 days or clear up and occur again

within a few days

• arthritic pain persists for more then 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 product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use(s)

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

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

Pain Relieving Gel

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

Directions

Shake well before each use.

Adults and children over 2 years:

• rub a thin film over affected area not more than 3 to 4 times daily

• wash hands after use with cool water

children under 2 years of age: ask a doctor

Other Information (Other information)

Store at 15ºC - 30ºC (59ºF - 86ºF).

Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Menthol 4%

Inactive Ingredients (Inactive ingredients)

blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5

Principal Display Panel
Roll on Gel
When Using This Product (When using this product)

• use only as directed

• avoid contact with 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 (Stop use and ask a doctor if)

• you experience pain, swelling or blistering of the skin

• condition worsens, or symptoms persist for more then 7 days or clear up and occur again

within a few days

• arthritic pain persists for more then 10 days, or redness is present, or in

conditions affecting children under 12 years of age

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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

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


Advanced Ingredient Data


Raw Label Data

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