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NDC 72520-0111-24 NUVALU VAPORIZING CHEST RUB 4.7; 1; 1 g/100g; g/100g; g/100g Details

NUVALU VAPORIZING CHEST RUB 4.7; 1; 1 g/100g; g/100g; g/100g

NUVALU VAPORIZING CHEST RUB is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by JC SALES. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL.

Product Information

NDC	72520-0111
Product ID	72520-111_7b3d5da1-f909-186c-e053-2991aa0a6b91
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 VAPORIZING CHEST RUB
Proprietary Name Suffix	n/a
Non-Proprietary Name	camphor, eucalyptus oil, menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	4.7; 1; 1
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; 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 72520-0111-24 (72520011124)

Pricing Information	N/A
NDC Package Code	72520-111-24
Billing NDC	72520011124
Package	113 g in 1 JAR (72520-111-24)
Marketing Start Date	2018-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7b3d5da1-f908-186c-e053-2991aa0a6b91 Details

Active Ingredients

Camphor, 4.7 percent

Eucalyptus Oil, 1 percent

Menthol, 1 percent

Purpose

Cough Suppressant and Topical Analgesic

Cough Suppressant

Cough Suppressant and Topical Analgesic

USES

on chest and throat, to temporarily relieve cough

use on aching muscles to temporarily relieve minor aches

WARNINGS:

For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

Consult a doctor and discontinue use;

If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash, or persistant headache.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS:

Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapors rise to nose and mouth. Repeat up to three times daily, especially at bed time, or as directed by a doctor. Children under two years of age, consult a doctor.

Inactive ingredients:

petrolatum, mineral oil, nutmeg, spirits of turpentine, cedarleaf oil, thymol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUVALU VAPORIZING CHEST RUB

camphor, eucalyptus oil, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72520-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.7 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
NUTMEG OIL (UNII: Z1CLM48948)
TURPENTINE (UNII: XJ6RUH0O4G)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
THYMOL (UNII: 3J50XA376E)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72520-111-24	113 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(72520-111)

Revised: 11/2018

Document Id: 7b3d5da1-f909-186c-e053-2991aa0a6b91

Set id: 7b3d5da1-f908-186c-e053-2991aa0a6b91

Version: 1

Effective Time: 20181101