Icy Hot Pro Pain Relief Cream With Microbeads

Icy Hot Pro Pain Relief Cream With Microbeads
SPL v4
SPL
SPL Set ID df5fd485-f583-46b7-a869-16ca2e17185c
Route
TOPICAL
Published
Effective Date 2026-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.16 g) Camphor (synthetic) (0.11 g)
Inactive Ingredients
Water Propanediol Steareth-21 Alcohol Glyceryl Monostearate Cetostearyl Alcohol Farnesol Stearic Acid Aloe Vera Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Pentylene Glycol 4-tert-butylcyclohexanol Potassium Hydroxide Allantoin Grapefruit Oil Peppermint Oil Spearmint Oil Jojoba Oil Menthyl Lactate, (-)- Ferric Ferrocyanide Diisopropyl Adipate Diethylene Glycol Monoethyl Ether Glyceryl Dilaurate Polysorbate 80 Peg-150 Stearate Soy Sterol Phenoxyethanol Methylparaben Glycerin Edetate Disodium Anhydrous Xanthan Gum Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-21

Description

ICY HOT PRO CREAM Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

ICY HOT PRO CREAM Drug Facts

Use

temporarily relieves minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

Section 42229-5

ICY HOT PRO CREAM

Drug Facts

Warnings

For external use only

Directions
  • adults and children 12 years of age and older:

    ▪ apply a thin layer to affected area not more than 3 to 4 times daily

    ▪ massage until thoroughly absorbed into skin

    ▪ wash hands thoroughly with soap and water after each use

  • 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

water, propanediol, steareth-21, alcohol denat., glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, jojoba esters, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, potassium hydroxide, allantoin, fragrance, citrus paradisi (grapefruit) peel oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, ethoxydiglycol, glyceryl dilaurate, polysorbate 80, PEG-150 stearate, glycine soja (soybean) sterols, phenoxyethanol, methylparaben, glycerin, disodium EDTA, xanthan gum, ferric ferrocyanide, citric acid

357-102

Close cap tightly after use.

Keep carton as it contains important information.

Principal Display Panel

IcyHot

Pro Pain Relief Cream


Net
Wt 2 OZ (56 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

Keep Out of Reach of Children.

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


Structured Label Content

Use

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 PRO CREAM

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only

Directions
  • adults and children 12 years of age and older:

    ▪ apply a thin layer to affected area not more than 3 to 4 times daily

    ▪ massage until thoroughly absorbed into skin

    ▪ wash hands thoroughly with soap and water after each use

  • 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)

water, propanediol, steareth-21, alcohol denat., glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, jojoba esters, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, potassium hydroxide, allantoin, fragrance, citrus paradisi (grapefruit) peel oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, ethoxydiglycol, glyceryl dilaurate, polysorbate 80, PEG-150 stearate, glycine soja (soybean) sterols, phenoxyethanol, methylparaben, glycerin, disodium EDTA, xanthan gum, ferric ferrocyanide, citric acid

357-102

Close cap tightly after use.

Keep carton as it contains important information.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

IcyHot

Pro Pain Relief Cream


Net
Wt 2 OZ (56 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

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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