Soothe and Cool Free Skin Paste

Dosage form: paste
Ingredients: Zinc Oxide 100mg in 1g, Petrolatum 500mg in 1g
Labeler: Medline Industries, Inc.
NDC Code: 53329-004

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.

Drug Facts

Active ingredients

Zinc Oxide 10% and White Petrolatum 50%

Purpose

Protectant

Use

Temporarily

    * forms a protective coating over inflamed tissues to help prevent drying
    * provides relief from skin irritations
    * helps relieve local itching and discomfort in the perianal area
    * protects irritated areas
    * relieves burning

Warnings

For external use only

When using this product
  • do not use in or near the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device

Stop use and ask a doctor if


  •     condition worsens or does not improve within 7 days.

In case of bleeding, consult a doctor promptly.

Keep out of reach of children

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

Directions
  • gently cleanse and dry affected area
  • apply liberally to affected area as needed

Other information

Protect from freezing, avoid excessive heat.

Inactive ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Benzethonium Chloride, Cholecalciferol, Eugenia Caryophyllus (Clove) Flower Oil, Retinyl Palmitate, Sterculia Urens Gum, Tocopheryl Acetate, Zea Mays (Corn) Oil

Principal Display Panel

Soothe and Cool Free

Skin Paste

A Thick, Protective Skin Barrier

SOOTHE AND COOL FREE SKIN PASTE 
zinc oxide and white petrolatum paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc) Zinc Oxide100 mg  in 1 g
Petrolatum (Petrolatum) Petrolatum500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Allantoin 
Benzethonium Chloride 
Cholecalciferol 
Clove Oil 
Vitamin A Palmitate 
Karaya Gum 
Corn Oil 
Packaging
#Item CodePackage Description
1NDC:53329-004-1071 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2007
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2009
 
Medline Industries, Inc.

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.

Hide
(web1)