VICKS VAPO RUB- camphor, mentol, eucalyptus oil ointment

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

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Active ingredient:
Camphor (synthetic) 4.8%, Eucalyptus oil 1.2%, Menthol 2.6%, Cough suppressant & topical analgesic, Cough suppressant, Cough suppressant & topical analgesic
Available from:
Savings Distributors LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
• when applied to chest or throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Authorization status:
OTC monograph final
Authorization number:
73097-015-01, 73097-015-24

VICKS VAPO RUB- camphor, mentol, eucalyptus oil ointment

Savings Distributors LLC

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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Vicks Vapo Rub

Drug Facts

Active ingredients

Camphor (synthetic) 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Purpose

Cough suppressant & topical analgesic

Cough suppressant

Cough suppressant & topical analgesic

Uses

when applied to chest or throat, temporarily relieves cough due to

minor throat and bronchial irritation associated with the

common cold

when applied to muscles and joints, temporarily relieves minor

aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

Do not use

by mouth in nostrils

on wounds or damaged skin with tight bandages

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 microwave

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 or persist for more than 7 days or

clear up and occur again within a few days.

cough persists for more than 1 week, tends to recur, or is

accompanied by fever, rash, or persistent headache. A persistent

cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

see important warnings under “When using this product”

adults and children 2 years and over:

for cough suppression

rub a thick layer on throat & chest

cover with a warm, dry cloth if desired

keep clothing loose about throat and chest to help vapors reach the

nose and mouth

use up to three times daily or as directed by doctor

for muscle / joint minor aches and pains apply to affected area not

more than 3 to 4 times daily

children under 2 years: do not use

Other information

store at room temperature

Inactive ingredients

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil.

Questions or comments?

1-800-873-8276

Package Label

VICKS VAPO RUB

camphor, mentol, eucalyptus oil ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 9 7-0 15(NDC:370 0 0 -544)

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)

0 .0 48 g

in 1 g

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

EUCALYPTUS OIL

0 .0 12 g in 1 g

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

MENTHOL

0 .0 26 g

in 1 g

Inactive Ingredients

Savings Distributors LLC

Ingredient Name

Stre ng th

CEDAR LEAF O IL (UNII: BJ16 9 U4NLG)

NUTMEG O IL (UNII: Z1CLM48 9 48 )

PETRO LATUM (UNII: 4T6 H12BN9 U)

THYMO L (UNII: 3J50 XA376 E)

TURPENTINE O IL (UNII: C5H0 QJ6 V7F)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 9 7-0 15-24

24 in 1 CARTON

0 7/22/20 19

1

12 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:730 9 7-0 15-0 1 12 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 7/22/20 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 7/22/20 19

Labeler -

Savings Distributors LLC (010527359)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Savings Distributo rs LLC

0 10 527359

re pa c k(730 9 7-0 15)

Revised: 8/2019

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