HEALTHWISE SOOTHING COLD THERAPY GEL- menthol 4% gel

HealthWise Soothing Cold Therapy Gel by

Drug Labeling and Warnings

HealthWise Soothing Cold Therapy Gel by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 4%

Purpose

Topical analgesic

Uses

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

■arthritis ■backache ■strains■sprains

Warnings

For external use only

Flammable: keep away from excessive heat or open flame

Ask a doctor before use if you have

• sensitive skin

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

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

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

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.

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

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

HealthWise Soothing Cold Therapy Gel 4% Menthol

INGREDIENTS AND APPEARANCE

HEALTHWISE SOOTHING COLD THERAPY GEL 
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
THYMOL (UNII: 3J50XA376E)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-050-01	1 in 1 BOX	08/01/2024
1		88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2022

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71101-050)