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Menthol and Zinc Oxide by Dynarex Corporation

Medically reviewed on May 22, 2018

Dosage form: ointment
Ingredients: MENTHOL .44g in 100g, ZINC OXIDE 21g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-234

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.

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;

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings:

Keep out of reach of children

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

Indications & Usage
  • Not for deep or puncture wounds.
  • Avoid contact with eyes.
  • If condition worsens or does not improve within 7 days, consult a doctor

Dosage & Administration:
  • Clean skin with mild skin cleanser
  • Pat dry or allow to air dry
  • Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection

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_Ointment.jpg

MENTHOL AND ZINC OXIDE  
menthol and zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-234
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.44 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
PHENOL 
LANOLIN 
MINERAL OIL 
SODIUM BICARBONATE 
THYMOL 
Packaging
#Item CodePackage Description
1NDC:67777-234-012 BOX (BOX) in 1 CASE
1144 POUCH (POUCH) in 1 BOX
13.5 g in 1 POUCH
2NDC:67777-234-0236 JAR (JAR) in 1 CASE
271 g in 1 JAR
3NDC:67777-234-0324 TUBE (TUBE) in 1 CASE
3113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/11/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

 
Dynarex Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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