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Soothe and Cool Free Medseptic Skin Protectant

Dosage form: ointment
Ingredients: LANOLIN 500mg in 1g
Labeler: Medline Industries, Inc.
NDC Code: 53329-042

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 ingredient

Lanolin, USP 50%


Purpose

Skin Protectant

Uses
  • Helps treat and prevent the symptoms of minor skin irritation caused by wetness, urine, and/or stool
  • Temporarily protects and helps relieve chapped or cracked skin
  • Helps seal out wetness

Warnings
  • For external use only
  • Do not get into eyes

Do not use on
  • deep or puncture wounds

  • animal bites

  • serious burns

Stop use and ask a doctor if
  • condition worsens or symptoms last more than 7 days

Keep out of reach of children.

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

Directions

Gently cleanse and dry affected area.

Apply liberally to affected area as needed.

Other information
  • Store at room temperature 20-25 C (68-77 F)

Inactive ingredients

8-Hydroxyquinoline, Aloe Barbadensis Leaf Juice, Beeswax, Cholecalciferol, Disodium EDTA, Methylparaben, Petrolatum, Propylparaben, Retinyl Palmitate, Sodium Borate, Sorbitan Sesquioleate, Tocopherol, Water (Purified), Zea Mays (Corn) Oil

SOOTHE AND COOL FREE MEDSEPTIC  SKIN PROTECTANT
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-042
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
CHOLECALCIFEROL 
EDETATE DISODIUM 
METHYLPARABEN 
OXYQUINOLINE 
PETROLATUM 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SODIUM BORATE 
WATER 
CORN OIL 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage Description
1NDC:53329-042-44113 g in 1 JAR
2NDC:53329-042-7714 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2007
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2016
 
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.

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