Icy Hot Max Lidocaine No Mess

Icy Hot Max Lidocaine No Mess
SPL v7
SPL
SPL Set ID 347f9a18-8ab6-47d3-9610-5b4e9ca5d53a
Route
TOPICAL
Published
Effective Date 2026-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Alcohol Aloe Vera Leaf Aminomethylpropanol C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Methicone Cetearyl Alcohol Ceteth-20 Phosphate Dicetyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Stearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Methylparaben Polysorbate 60 Steareth-2 Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-10

Description

ICY H OT with LIDOCAINE CREAM (MAX) Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

ICY H OT with LIDOCAINE CREAM (MAX) Drug Facts

Use

for the temporary relief of pain

Section 42229-5

ICY H OT with LIDOCAINE CREAM (MAX)

Drug Facts

Active I

Lidocaine HCl 4%

Warnings

For external use only

Flammable

   keep away from heat and open flame.

Directions

■ adults and children 12 years of age and older:

        ■ apply a thin layer to affected area every 6 to 8 hours, 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

 in large quantities 

 on wounds or on irritated or damaged skin

■ with a heating pad

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-2, steareth-21, water

Child-resistant packaging. Close cap tightly after use .

Keep carton as it contains important information.

Principal Display Panel

ICYHOT

WITH LIDOCAINE
4%

NO-MESS

ROLL ON


PAIN RELIEF


1.5 fl oz (44.3 mL)

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 to direct sunlight

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

for the temporary relief of pain

Section 42229-5 (42229-5)

ICY H OT with LIDOCAINE CREAM (MAX)

Drug Facts

Purpose

Topical anesthetic

Active I (Active i)

Lidocaine HCl 4%

Warnings

For external use only

Flammable

   keep away from heat and open flame.

Directions

■ adults and children 12 years of age and older:

        ■ apply a thin layer to affected area every 6 to 8 hours, 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)

 in large quantities 

 on wounds or on irritated or damaged skin

■ with a heating pad

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-2, steareth-21, water

Child-resistant packaging. Close cap tightly after use .

Keep carton as it contains important information.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ICYHOT

WITH LIDOCAINE
4%

NO-MESS

ROLL ON


PAIN RELIEF


1.5 fl oz (44.3 mL)

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 to direct sunlight

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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