CALMODROX- menthol, zinc oxide ointment 
Geritrex Corp

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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Calmodrox Ointment

Drug Facts

Active Ingredient                       Purpose

Menthol 0.44%                     External analgesic

                                           First aid antiseptic antipruritic

Zinc Oxide 20.0%                 Skin protectant/moisture barrier

Uses

A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

Directions

Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection

Warnings

FOR EXTERNAL USE ONLY

Not for deep or puncture wounds

Avoid contact with eyes

If condition worsens or does not improve within 7 days, consult a doctor

Inactive Ingredients

Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol

KEEP OUT OF REACH OF CHILDREN

In the event of accidental ingestion contact a Poison Control Center right away

Storage

Store at room temperature 15°-30°C (59°-86°F)

Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily.

Label of Tube

CALMODROX 
menthol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
PHENOL (UNII: 339NCG44TV)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
THYMOL (UNII: 3J50XA376E)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-219-04113 g in 1 TUBE01/22/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/22/2015
Labeler - Geritrex Corp (112796248)
Registrant - Geritrex Corp (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex Corp112796248manufacture(54162-219)

Revised: 2/2015
Document Id: 8e3d4a50-2206-4132-890c-9c08296e62bb
Set id: 724ac9d2-8567-43cc-9eb2-e83fbb542a87
Version: 1
Effective Time: 20150212
 
Geritrex Corp