ASSURED VAPORIZING CHEST RUB- menthol camphor eucalyptus oil gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Camphor 4.7 % Eucalyptus Oil 1% Menthol 2%
Available from:
Royal Exports
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Decongestant - temporarily relieves nasal congestion, chest congestion, and cough due to the common cold - temporarily relieves minor aches and pains - you are pregnant or breast feeding - you have ashtma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus - If mucus lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache - open flame - microwave oven - a container in which water is being heated except when adding cold water to a hot stream vaporizer
Authorization status:
OTC monograph final
Authorization number:
51328-2060-1

ASSURED VAPORIZING CHEST RUB- menthol camphor eucalyptus oil gel

Royal Exports

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Assured Chest Rub

Active Ingredients

Camphor 4.7 % Eucalyptus Oil 1% Menthol 2%

Purpose

Decongestant

Uses

temporarily relieves nasal congestion, chest congestion, and cough due to the common cold

temporarily relieves minor aches and pains

Warnings :

FOR EXTERNAL USE ONLY

When using this product

Avoid contact with eyes

Do not put into mouth, nostrils or on wounds or damaged skin

Consult a doctor before use if

you are pregnant or breast feeding

you have ashtma, emphysema, persistent or chronic cough, cough associated with smoking or

excessive mucus

If mucus lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache

Do not use near

open flame

microwave oven

a container in which water is being heated except when adding cold water to a hot stream vaporizer

Keep out of reach of children

If ingested, get medical help or contract a Poison Control Center right away

Directions

Adults and children 2 years of age and older

rub 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, 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

PACKAGE LABEL

ASSURED VAPORIZING CHEST RUB

menthol camphor eucalyptus oil gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51328 -20 6 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

5.3 g in 113 g

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) (EUCALYPTUS OIL - UNII:2R0 4ONI6 6 2)

EUCALYPTUS OIL

1.13 g in 113 g

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

2.26 g

in 113 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

NUTMEG O IL (UNII: Z1CLM48 9 48 )

TURPENTINE O IL (UNII: C5H0 QJ6 V7F)

THYMO L (UNII: 3J50 XA376 E)

CEDAR LEAF O IL (UNII: BJ16 9 U4NLG)

Royal Exports

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51328 -20 6 0 -1

113 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 3/21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 3/21/20 19

Labeler -

Royal Exports (650621381)

Revised: 3/2019

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