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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

Use
  • protects and helps relieve the symptoms of minor skin irritation
  • helps seal out wetness
  • emollient

Warnings

For external use only

When using this product
  • do not use in or near the eyes

Do not use

on

  • deep or puncture wounds

  • animal bites

  • serious burns

Stop use and ask a doctor if
  • condition worsens
  • symptoms persist for more than 7 days, or clear upand occur again within a few 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

Protect from freezing.

Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice

Beeswax

Cholecalciferol

Disodium EDTA

Methylparaben

Oxyquinoline, Petrolatum

Propylparaben

Retinyl Palmitate

Sodium Borate

Sorbitan Sesquioleate

Tocopherol

Water

Zea Mays (Corn) Oil

Principal Display Panel

Soothe and Cool Free

Medseptic Skin Protectant

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 
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)
Establishment
NameAddressID/FEIOperations
Dhaliwal Labs Illinois,LLC079679410manufacture(53329-042)

Revised: 01/2016
 
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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