arthritis hot

arthritis hot
SPL v6
SPL
SPL Set ID cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd
Route
topical
Published
Effective Date 2025-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 g) salicylic acid (15 g)
Inactive Ingredients
cetyl esters wax diisopropyl adipate oleth-3 phosphate stearic acid water carbomer homopolymer, unspecified type trolamine cetearyl alcohol polysorbate 60

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1998-12-01

Purpose

Topical analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Purpose

Topical analgesic

Directions

adults and children over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive Ingredients

Carbomer, cetearyl alcohol, cetyl esters, diisapropyl adipate, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

Arthritis Hot Cream

Description

Drug Facts

Principal Display Panel

NDC 41167-0600-4

Arthritis Penetrating Pain Relief Cream

NET WT 3 OZ (85g)

Section 42229-5

Drug Facts

Active Ingredients

Menthol 10%

Methyl salicylate 15%

When Using This Product

■  use only as directed. Read and follow all directions and warnings on this label.

■  rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

Stop Use and Ask A Doctor If
  • condition worsens

  • redness is present

  • Irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Purpose

Topical analgesic

Directions

adults and children over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 3 to 4 times daily

■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive Ingredients (Inactive ingredients)

Carbomer, cetearyl alcohol, cetyl esters, diisapropyl adipate, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

Arthritis Hot Cream

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 41167-0600-4

Arthritis Penetrating Pain Relief Cream

NET WT 3 OZ (85g)

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients (Active ingredients)

Menthol 10%

Methyl salicylate 15%

When Using This Product (When using this product)

■  use only as directed. Read and follow all directions and warnings on this label.

■  rare cases of serious burns have been reported with products of this type

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or irritated skin

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • redness is present

  • Irritation develops

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

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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