VICKS VAPORUB CHILDRENS (camphor- synthetic, eucalyptus oil, and menthol ointment

Vicks VapoRub by

Drug Labeling and Warnings

Vicks VapoRub by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Camphor (synthetic) 4.8%
Eucalyptus oil 1.2%
Menthol 2.6%

Cough suppressant & topical analgesic
Cough suppressant
Cough suppressant & topical analgesic

Uses

• when applied to chest and 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 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?

1-800-873-8276

SPL UNCLASSIFIED SECTION

MADE INMEXICO
DIST. BY PROCTER&GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

VICKS ®

VapoRub ™

children's

COUGH SUPPRESSANT
TOPICAL ANALGESIC

Ointment

NET WT
1.76 OZ (50 g)

For children 2 years+

INGREDIENTS AND APPEARANCE

VICKS VAPORUB  CHILDRENS
camphor (synthetic), eucalyptus oil, and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-546
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.026 g  in 1 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58933-546-50	1 in 1 CARTON	07/11/2017
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/11/2017

Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)