CALADROX- menthol, zinc oxide ointment 
Geritrex 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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Caladrox 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. Pat dry or allow to air dry. Apply a thin layer of Caladrox 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 Caladrox Ointment to reddened or irritated skin 2-4 times daily.

Label of Tube

CALADROX 
menthol, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-229
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 CATION - UNII:13S1S8SF37) ZINC CATION20 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:54162-229-04113 g in 1 TUBE; Type 0: Not a Combination Product09/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/29/2015
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex LLC112796248manufacture(54162-229)

Revised: 9/2015
Document Id: 5977ea44-7dbe-476e-9691-421d2b5d14f6
Set id: 0fb20544-54bd-4f7a-8372-8a4dd1d79d21
Version: 1
Effective Time: 20150929
 
Geritrex LLC