MENTHOL AND ZINC OXIDE - menthol and zinc oxide  ointment 
Dynarex Corporation

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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Calasoothe Ointment

Active Ingredient                         Purpose

Menthol 0.44% v/v                            External Analgesic

                                                          First Aid Antiseptic

                                                          Antipuritic

Zinc Oxide 20.625% v/v                       Skin Protectant

                                                           Moisture Barrier         

Purpose:

A moisture barrier that prevents and helps heal skin irritations from;

Warnings:

Keep out of reach of children

Indications & Usage

Dosage & Administration:

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

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

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerine, Phenol, Lanolin, Heavy Liquid Paraffin, Sodium Bicarbonate, Thymol, White Soft Paraffin

Principal Display Panel

Principal Display Panel - Calasoothe_Ointment

Calasoothe.jpg

Calasoothe Ointment

MENTHOL AND ZINC OXIDE  
menthol and zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
THYMOL (UNII: 3J50XA376E)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-409-013.5 g in 1 POUCH
2NDC:67777-409-0271 g in 1 JAR
3NDC:67777-409-03113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/11/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 10/2014
Document Id: eb1c3ee3-da0c-4fc9-b9ca-dae83ae09492
Set id: fa1feac2-a28c-4bc1-bbf0-aeee74ac607f
Version: 1
Effective Time: 20141007
 
Dynarex Corporation