Healthwise Soothing Cold Therapy Gel 4% Menthol

Healthwise Soothing Cold Therapy Gel 4% Menthol
SPL v2
SPL
SPL Set ID 1f09ccdd-09d8-6a8d-e063-6394a90a184f
Route
TOPICAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Paraffin Cedar Leaf Oil Nutmeg Oil Thymol Turpentine Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:

■arthritis ■backache ■strains■sprains

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only

Flammable: keep away from excessive heat or open flame

Directions

Directions

Adults and children 2 years of age and older:■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician

Other Information
  • store in a cool dry place
  • do not use if tube seal under cap is broken
Active Ingredients



Menthol 4%

Inactive Ingredients

Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow

no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

Stop Use and Ask A Doctor If

Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur

When Using This Product, Do Not

When using this product:

■ avoid contact with eyes or mucous membranes

■ do not apply to wounds or damaged skin

■ do not use with other ointments, creams, sprays

or liniments

■do not apply to irritated skin or if excessive irritation develops

■do not bandage

■ wash hands after use with cool water

■do not use with a heating pad or device

Ask A Doctor Before Use If You Have
  • sensitive skin
Healthwise Soothing Cold Therapy Gel 4% Menthol


Structured Label Content

Uses

Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:

■arthritis ■backache ■strains■sprains

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center (800-222-1222) right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical analgesic

Warnings

For external use only

Flammable: keep away from excessive heat or open flame

Directions

Directions

Adults and children 2 years of age and older:■rub a thin film over affected area not more than 4 times daily, massage not necessary Children under 2 years of age: consult physician

Other Information (Other information)
  • store in a cool dry place
  • do not use if tube seal under cap is broken
Active Ingredients (Active ingredients)



Menthol 4%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients aloe barbadensis leaf juice, aminomethyl propanol,arctium lappa extract, arnica montana flower extract, Boswellia serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&Cyellow

no.5, FD&C blue no.1, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol,isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer, tocopheryl acetate, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if: the condition worsens, if the symptoms last more than 7 days or clear up and reoccur

When Using This Product, Do Not (When using this product, do not)

When using this product:

■ avoid contact with eyes or mucous membranes

■ do not apply to wounds or damaged skin

■ do not use with other ointments, creams, sprays

or liniments

■do not apply to irritated skin or if excessive irritation develops

■do not bandage

■ wash hands after use with cool water

■do not use with a heating pad or device

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • sensitive skin
Healthwise Soothing Cold Therapy Gel 4% Menthol (HealthWise Soothing Cold Therapy Gel 4% Menthol)


Advanced Ingredient Data


Raw Label Data

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