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NDC 81984-0099-01 4OZ MEDICATED CHEST RUB 4.7; 1; 1 g/100g; g/100g; g/100g Details

4OZ MEDICATED CHEST RUB 4.7; 1; 1 g/100g; g/100g; g/100g

4OZ MEDICATED CHEST RUB is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Pride Products Corporation. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL.

Product Information

NDC	81984-0099
Product ID	81984-099_60c0bc37-83b2-3280-e053-2a91aa0ae7c9
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	4OZ MEDICATED CHEST RUB
Proprietary Name Suffix	n/a
Non-Proprietary Name	menthol, camphor, eucalyptus oil
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
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	Pride Products Corporation
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 81984-0099-01 (81984009901)

Pricing Information	N/A
NDC Package Code	81984-099-01
Billing NDC	81984009901
Package	110 g in 1 JAR (81984-099-01)
Marketing Start Date	2017-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60c0bc37-83b1-3280-e053-2a91aa0ae7c9 Details

ACTIVE INGREDIENTS

Active Ingredients Purpose

Menthol 1.0% Decongestant

camphor 4.7% Decongestant

Eucalyptus Oil 1.0 % Decongestant

Purpose

Decongestant

USE:

To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

Warnings:

For external use only. Not for internal use. Avoil contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.

If pregnant or breast feeding,

consult a physician before use.

SPL UNCLASSIFIED SECTION

Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

Consult a physician before use.

If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back or if cough lasts more than 7 days, come back or occurs with fever, rash or a persistent headache.

Keep out of reach of children.

If ingested, get medical help or contact a Posion Control Center right away.

Directions:

Adults and children 2 years of age and older rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. If desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. children under 2 years of age, consult your physician.

Inactive Ingredients:

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

4OZ MEDICATED CHEST RUB

menthol, camphor, eucalyptus oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81984-099
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
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1 g in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
NUTMEG OIL (UNII: Z1CLM48948)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
THYMOL (UNII: 3J50XA376E)
CEDAR LEAF OIL (UNII: BJ169U4NLG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81984-099-01	110 g in 1 JAR; Type 0: Not a Combination Product	12/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2017

Labeler - Pride Products Corporation (112666285)

Registrant - Pride Products Corporation (112666285)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(81984-099)

Revised: 12/2017

Document Id: 60c0bc37-83b2-3280-e053-2a91aa0ae7c9

Set id: 60c0bc37-83b1-3280-e053-2a91aa0ae7c9

Version: 1

Effective Time: 20171220