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Lantiseptic Dry Skin Therapy

Dosage form: cream
Ingredients: LANOLIN 370mg in 1g
Labeler: Summit Industries, Inc.
NDC Code: 12090-0016

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.

Lantiseptic Dry Skin Therapy Therapeutic Cream Drug Facts

Active Ingredient

Lanolin USP 37%

Purpose

Skin Protectant

Uses
  • Helps protect ulcer prone skin.
  • For treatment of cracked skin, minor burns or irritation.
  • Helps prevent chafing and dryness.

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • Do not apply to deep or puncture wounds.
  • If condition worsens, or does not improve within 7 days, consult a doctor.
  • If swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of reach of children.

Directions
  • ​Gently cleanse and dry area.
  • Massage liberally into affected area as needed.
  • Cover treated feet.

Other Information

Store at 20-25°C (68-77°F)

Inactive Ingredients:

Beeswax (yellow wax), Fragrance, HEEDTA, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

If you have questions or comments, call

800-241-6996 or visit

www.Lantiseptic.com

SUMMIT INDUSTRIES, INC

Lantiseptic Division

PO BOX 7329

Marietta, GA 30065

Image of representative container

TC_113.jpg

LANTISEPTIC  DRY SKIN THERAPY
lanolin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-0016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN370 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID 
LANOLIN ALCOHOLS 
MINERAL OIL 
OXYQUINOLINE 
PETROLATUM 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage Description
1NDC:12090-0016-214.2 g in 1 PACKET
2NDC:12090-0016-1113 g in 1 TUBE
3NDC:12090-0016-3227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34712/30/2009
Labeler - Summit Industries, Inc. (003279189)
Registrant - Summit Industries, Inc. (003279189)
Establishment
NameAddressID/FEIOperations
Summit Industries, Inc.003279189manufacture(12090-0016)

Revised: 01/2013
Document Id: 7b7da226-297a-4f44-aa94-fdf34d64a9da
Set id: 9a20eba3-6f27-4dba-9ea4-8b3ce9b84891
Version: 2
Effective Time: 20130121
 
Summit 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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