Icy Hot Pro Pain Relief Massaging Balm

Icy Hot Pro Pain Relief Massaging Balm
SPL v6
SPL
SPL Set ID 09e2b0cb-5186-4f9c-b256-edaced4ca014
Route
TOPICAL
Published
Effective Date 2026-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (.16 g) Camphor (synthetic) (.11 g)
Inactive Ingredients
Almond Oil Helianthus Annuus Seed Wax Cocoa Butter Coconut Oil Avocado Oil Hydrogenated Avocado Oil Carnauba Wax Synthetic Beeswax Grapefruit Oil Eucalyptus Oil Peppermint Oil Spearmint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

Icy Hot P RO   Pain Relief Massaging Balm Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Icy Hot P RO   Pain Relief Massaging Balm Drug Facts

Uses

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

  • arthritis

  • simple backache

  • strains

  • sprains

  • bruises
Section 42229-5

Icy Hot P RO   Pain Relief Massaging Balm

Drug Facts

Warnings

For external use only

Directions
  • adults and children 12 years of age and older:
    • massage into affected area using the no-mess balm not more than 3 to 4 times daily

    • wash hands thoroughly with soap and water if product comes in contact with hands


  • children under 12 years of age: ask a doctor
Do Not Use
  • on wounds or on irritated or damaged skin

  • with a heating pad
Active Ingredient

Camphor 11% 

Menthol 16%

Inactive Ingredients

prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

Close cap tightly after use. Keep carton as it contains important information.

Keep carton as it contains important information. 

     

Principal Display Panel

ICY HOT

ADVANCED PRO

MASSAGING BALM

PAIN RELIEF

NET WT 1.25 OZ (35 g)

When Using This Product
  • use only as directed

  • do not bandage tightly

  • avoid contact with eyes and mucous membranes

  • do not expose the area to local heat or direct sunlight

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

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

  • avoid applying into skin folds
Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days

  • symptoms clear up and occur again within a few days

  • redness is present or excessive skin irritation occurs

  • you experience severe burning pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

This product is not a toy or intended for use by children.

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


Structured Label Content

Uses

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

  • arthritis

  • simple backache

  • strains

  • sprains

  • bruises
Section 42229-5 (42229-5)

Icy Hot P RO   Pain Relief Massaging Balm

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only

Directions
  • adults and children 12 years of age and older:
    • massage into affected area using the no-mess balm not more than 3 to 4 times daily

    • wash hands thoroughly with soap and water if product comes in contact with hands


  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • on wounds or on irritated or damaged skin

  • with a heating pad
Active Ingredient (Active ingredient)

Camphor 11% 

Menthol 16%

Inactive Ingredients (Inactive ingredients)

prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

Close cap tightly after use. Keep carton as it contains important information.

Keep carton as it contains important information. 

     

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ICY HOT

ADVANCED PRO

MASSAGING BALM

PAIN RELIEF

NET WT 1.25 OZ (35 g)

When Using This Product (When using this product)
  • use only as directed

  • do not bandage tightly

  • avoid contact with eyes and mucous membranes

  • do not expose the area to local heat or direct sunlight

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

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

  • avoid applying into skin folds
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days

  • symptoms clear up and occur again within a few days

  • redness is present or excessive skin irritation occurs

  • you experience severe burning pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

This product is not a toy or intended for use by children.

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


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