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NDC 72520-0112-24 NUVALU ICE THERAPY MENTHOL PAIN RELIEVING 1 g/100g Details

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING 1 g/100g

NUVALU ICE THERAPY MENTHOL PAIN RELIEVING is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by JC SALES. The primary component is MENTHOL.

Product Information

NDC	72520-0112
Product ID	72520-112_7b4dcca8-dc9a-0bc5-e053-2991aa0a7582
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	NUVALU ICE THERAPY MENTHOL PAIN RELIEVING
Proprietary Name Suffix	n/a
Non-Proprietary Name	menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	MENTHOL
Labeler Name	JC SALES
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72520-0112-24 (72520011224)

Pricing Information	N/A
NDC Package Code	72520-112-24
Billing NDC	72520011224
Package	227 g in 1 JAR (72520-112-24)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7b4dcca8-dc99-0bc5-e053-2991aa0a7582 Details

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:72520-112
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72520-112-24	227 g in 1 JAR; Type 0: Not a Combination Product	11/01/2018

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

Labeler - JC SALES (610969578)

Registrant - JC SALES (610969578)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(72520-112)

Revised: 11/2018

Document Id: 7b4dcca8-dc9a-0bc5-e053-2991aa0a7582

Set id: 7b4dcca8-dc99-0bc5-e053-2991aa0a7582

Version: 1

Effective Time: 20181101