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NDC 50804-0078-01 MEDICATED CHEST RUB .048; .012; .026 g/g; g/g; g/g Details

MEDICATED CHEST RUB .048; .012; .026 g/g; g/g; g/g

MEDICATED CHEST RUB is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by GOODSENSE. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	50804-0078
Product ID	50804-078_17a7f29b-8d88-493b-b54a-ce45403df0f0
Associated GPIs
GCN Sequence Number	063554
GCN Sequence Number Description	eucalyptus oil/menthol/camphor OINT. (G) 1.2%-4.8% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	99276
HICL Sequence Number	019918
HICL Sequence Number Description	EUCALYPTUS OIL/MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	MEDICATED CHEST RUB
Proprietary Name Suffix	n/a
Non-Proprietary Name	camphor (synthetic), eucalyptus oil, and menthol, unspecified form
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.048; .012; .026
Active Ingredient Units	g/g; g/g; g/g
Substance Name	CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM
Labeler Name	GOODSENSE
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0078-01 (50804007801)

Pricing Information	N/A
NDC Package Code	50804-078-01
Billing NDC	50804007801
Package	100 g in 1 JAR (50804-078-01)
Marketing Start Date	2021-02-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f18ff94f-8716-4514-93f8-e101867e1c8b Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purposes
Camphor 4.8%	Cough suppressant & topical analgesic
Eucalyptus oil 1.2%	Cough suppressant
Menthol 2.6%	Cough suppressant & topical analgesic

Uses

on chest & throat, temporarily relieves cough due to the common cold
on muscles and joints, temporarily relieves minor aches and pains

Warnings

For external use only; avoid contact with eyes.

Do not use

by mouth
with tight bandages
in nostrils
on wounds or damaged skin

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product

do not heat
do not microwave
do not add to hot water or any container where heating water. May cause splattering and result in burns.

Stop use and ask a doctor if

muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days
cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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 Poison Control Center right away: 800-222-1222.

Directions

see important warnings under "When using this product"

Adults and children 2 years old and older:
- rub a thick layer on chest & throat for cough, or rub on sore aching muscles or joints
- cover with a warm, dry cloth if desired
- keep clothing loose about throat/chest to help vapors reach the nose/mouth
- repeat up to three times daily or as directed by a doctor
Children under 2 years: do not use

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON JAR IS BROKEN OR MISSING.

Inactive ingredients

cedarleaf oil, nutmeg oil, spirits of turpentine, thymol, white petrolatum

Questions or comments?

866-323-0107

SPL UNCLASSIFIED SECTION

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 100 g Jar Label

GOODSENSE®

NDC# 50804-078-01

Medicated

Chest Rub

Nasal Decongestant
Cough Suppressant
Topical Analgesic

Compare to active ingredients of

Vicks® VapoRub®*

100%

SATISFACTION

GUARANTEED

NET WT 3.53 OZ (100 g)

Principal Display Panel - 100 g Jar Label

INGREDIENTS AND APPEARANCE

MEDICATED CHEST RUB

camphor (synthetic), eucalyptus oil, and menthol, unspecified form ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-078
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.048 g in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.012 g in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.026 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CEDAR LEAF OIL (UNII: BJ169U4NLG)
NUTMEG OIL (UNII: Z1CLM48948)
TURPENTINE OIL (UNII: C5H0QJ6V7F)
THYMOL (UNII: 3J50XA376E)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-078-01	100 g in 1 JAR; Type 0: Not a Combination Product	02/11/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/11/2021

Labeler - GOODSENSE (076059836)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(50804-078)

Revised: 2/2021

Document Id: 17a7f29b-8d88-493b-b54a-ce45403df0f0

Set id: f18ff94f-8716-4514-93f8-e101867e1c8b

Version: 1

Effective Time: 20210216

Search by Drug Name or NDC

NDC 50804-0078-01 MEDICATED CHEST RUB .048; .012; .026 g/g; g/g; g/g Details

MEDICATED CHEST RUB .048; .012; .026 g/g; g/g; g/g

Product Information

Package

Package Images

NDC 50804-0078-01 (50804007801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f18ff94f-8716-4514-93f8-e101867e1c8b Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 100 g Jar Label

INGREDIENTS AND APPEARANCE

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