NUVALU ICE THERAPY MENTHOL PAIN RELIEVING- menthol gel

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING by

Drug Labeling and Warnings

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by Ningbo Liyuan Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients

Menthol 1.25 percent

Purpose

Topical Analgesic

USE:

for the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache, strains, sprains, sports injuries, arthritis, bruises

Warnings:

For external use only

Do not use

• with other topical pain relievers
• with heating pads or heating devices

When using this product

• Do not use in or near eyes
• Do not apply to wounds or damaged skin
• Do not bandage tightly

Stop use and ask doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• redness or irritation develops

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 Posion Control Center right away.

Directions:

• Clean affected area before applying product
• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Inactive Ingredients:

Water (Aqua), Ethyl Alcohol, Camphor, Carbomer, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Triethanolamine, FD&C Blue No.1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76176-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER 934 (UNII: Z135WT9208)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76176-222-24	227 g in 1 JAR; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2018

Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)

Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(76176-222)