NDC Code(s) : 54565-3601-1, 54565-3601-2
Packager : Les Emballages Knowlton Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vicks VapoSteamCamphor (synthetic) LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54565-3601
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET)
(CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) 		CAMPHOR (SYNTHETIC)0.062 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
POLOXAMER 124(UNII: 1S66E28KXA)
LAURETH-7(UNII: Z95S6G8201)
EUCALYPTUS OIL(UNII: 2R04ONI662)
CEDAR LEAF OIL(UNII: BJ169U4NLG)
NUTMEG OIL(UNII: Z1CLM48948)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54565-3601-21 in 1 CARTON 11/03/2017
1NDC:54565-3601-1236 mL in 1 BOTTLE, PLASTIC 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 11/03/2017

PRINCIPAL DISPLAY PANEL

VICKS ®

Vapo

Steam ®

Camphor

COUGH SUPPRESSANT

FOR USE IN HOT STEAM VAPORIZERS

  • Produces Medicated Steam that Helps to Relieve Coughs!

DO NOT TAKE BY MOUTH

8 FL OZ (236 ml)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton