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

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Section 42229-5

Drug Facts

Warnings

For external use only

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

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

Active Ingredients

Menthol 10%

Methyl salicylate 15%

Inactive Ingredients

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

Arthritis Hot Cream

Principal Display Panel

NDC 41167-0600-4

Arthritis Penetrating Pain Relief Cream

NET WT 3 OZ (85g)

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

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Section 42229-5 (42229-5)

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only

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

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

Active Ingredients (Active ingredients)

Menthol 10%

Methyl salicylate 15%

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)

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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