healthwise menthol 4% roll-on

healthwise menthol 4% roll-on
SPL v1
SPL
SPL Set ID 1894ef00-ba05-0e02-e063-6394a90ab982
Route
topical
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (4 g)
Inactive Ingredients
glycerin aloe vera leaf carbomer 940 camphor (natural) trolamine alcohol arnica montana flower water isopropyl myristate calendula officinalis flower .alpha.-tocopherol acetate melissa officinalis leaf arctium lappa whole green tea leaf ilex paraguariensis leaf indian frankincense methyl methacrylate/glycol dimethacrylate crosspolymer fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-01

Purpose

Topical analgesic

Description

HealthWise Menthol 4% Roll-On


Medication Information

Warnings

For external use only

Uses

Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle

strains ■ sprains ■ bruises ■ cramps

Purpose

Topical analgesic

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

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water



Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone

crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane,

phenoxyethanol, SD alcohol, steareth-21, water



Description

HealthWise Menthol 4% Roll-On

Principal Display Panel

Section 42229-5

HealthWise Menthol 4% Roll-On

Active Ingredient

Menthol 4%

Questions Or Comments

Call 1-866-326-1313

When Using This Product

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton

■ 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 the product to heat or direct sunlight

■ avoid applying into skin folds

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

Flammable■ Keep away from fire or flame

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 (1-800-222-1222) right away.


Structured Label Content

Warnings

For external use only

Uses

Uses Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle

strains ■ sprains ■ bruises ■ cramps

Purpose

Topical analgesic

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

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water



Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone

crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane,

phenoxyethanol, SD alcohol, steareth-21, water



Principal Display Panel

Section 42229-5 (42229-5)

HealthWise Menthol 4% Roll-On

Active Ingredient (Active ingredient)

Menthol 4%

Questions Or Comments (Questions or comments)

Call 1-866-326-1313

When Using This Product (When using this product)

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton

■ 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 the product to heat or direct sunlight

■ avoid applying into skin folds

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

Flammable■ Keep away from fire or flame

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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