Icy Hot Kids Pain Relief Roll-on

Icy Hot Kids Pain Relief Roll-on
SPL v2
SPL
SPL Set ID 5466e3ce-e591-40e9-a83f-40ac626418d2
Route
TOPICAL
Published
Effective Date 2023-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Citric Acid Monohydrate Diisopropyl Adipate Ethylhexylglycerin Glycerin Hydroxyacetophenone Potassium Hydroxide Steareth-2 Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-15

Description

Icy Hot Kids Pain Relief Roll - On Drug Facts

Purpose

Menthol 4%.........................................................................................................................Topical analgesic


Medication Information

Purpose

Menthol 4%.........................................................................................................................Topical analgesic

Description

Icy Hot Kids Pain Relief Roll - On Drug Facts

Uses

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

■ sprains ■ bruises ■ simple backache    

Section 42229-5

Icy Hot Kids Pain Relief Roll - On

Drug Facts

Warnings

For external use only

Directions

■ children 2 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 2 years of age: ask a doctor

Do Not Use

■ on wounds or on irritated or damaged skin

■ with a heating pad

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water

PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION .   Close cap tightly after use.

Keep carton as it contains important information.

Principal Display Panel

Icy Hot

Kids Pain Relief

Roll-On

1.5 FL OZ (44.3 mL) ROLL-ON

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

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.

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:    ■ strains

■ sprains ■ bruises ■ simple backache    

Section 42229-5 (42229-5)

Icy Hot Kids Pain Relief Roll - On

Drug Facts

Purpose

Menthol 4%.........................................................................................................................Topical analgesic

Warnings

For external use only

Directions

■ children 2 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 2 years of age: ask a doctor

Do Not Use (Do not use)

■ on wounds or on irritated or damaged skin

■ with a heating pad

Inactive Ingredients (Inactive ingredients)

allantoin, aloe barbadensis leaf juice, carbomer, citric acid, diisopropyl adipate, ethylhexylglycerin, glycerin, hydroxyacetophenone, potassium hydroxide, steareth-2, steareth-21, water

PRODUCT SHOULD BE APPLIED UNDER ADULT SUPERVISION .   Close cap tightly after use.

Keep carton as it contains important information.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Icy Hot

Kids Pain Relief

Roll-On

1.5 FL OZ (44.3 mL) ROLL-ON

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

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.)

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


Advanced Ingredient Data


Raw Label Data

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