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Lantiseptic Original Skin Protectant

Dosage form: cream
Ingredients: LANOLIN 500mg in 1g
Labeler: Santus LLC
NDC Code: 12090-0019

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 Original Skin Protectant Cream

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

• Helps prevent and treat skin irritations. • Protects chafed skin or minor skin irritations due to incontinence •Helps seal out wetness.

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. • Apply liberally to affected area as needed.

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients

Beeswax (Yellow Wax), Disodium EDTA, DMDM Hydantoin + IPBC, Lanolin Alcohol, Mineral Oil, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate.

Questions or Comments?

844-7SANTUS or visit www.lantiseptic.com

Package Labeling:

LANTISEPTIC ORIGINAL SKIN PROTECTANT 
lanolin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-0019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN500 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
EDETATE DISODIUM 
LANOLIN ALCOHOLS 
MINERAL OIL 
PETROLATUM 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage Description
1NDC:12090-0019-65 g in 1 PACKET
2NDC:12090-0019-114.2 g in 1 PACKET
3NDC:12090-0019-3113 g in 1 TUBE
4NDC:12090-0019-4130 g in 1 JAR
5NDC:12090-0019-71 JAR in 1 CARTON
5340 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/03/2016
Labeler - Santus LLC (079868223)

Revised: 03/2016
 
Santus LLC

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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