Lantiseptic Ointment Classification Essay

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%

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: 01/2017
 

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.

Lantiseptic Skin Protectant (Topical) Drug and Prescription Information

Lantiseptic Skin Protectant (Topical)

Lantiseptic Skin Protectant (Topical) Medication Classification

TOPICAL BARRIER PREPARATIONS (On the skin)

Lantiseptic Skin Protectant (Topical) Brandname

Lantiseptic Skin Protectant, Dermadrox, Step 3 Moisture Barrier, Soothe & Cool Moisture Barrier, Lobana Peri-Garde, Handshield, Lantiseptic Therapeutic, D-R-C Peri-Rectal Creme, Sbr-Lipocream, Soothe & Cool Inzo, Carrington Moisture Barrier, Prean

Lantiseptic Skin Protectant (Topical) is used for the Treatment

Treats and prevents diaper rash, severely dry or chapped skin, minor burns, and other skin irritations.

When To Not Use Lantiseptic Skin Protectant (Topical)

You should not use this medicine if you have had an allergic reaction to petrolatum, lanolin, dimethicone, or zinc oxide.

How Should You Use Lantiseptic Skin Protectant (Topical)

Ointment, Cream, Lotion, Pad, Swab, Spray, Paste

  • Change wet and soiled diapers right away. Clean the diaper area and allow to dry.
  • Clean minor wounds before applying this medicine.
  • This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
  • Apply a thin layer to the affected area. Rub it in gently. Do not rub in the medicine that came in a pad, swab, or spray. Allow the pad, swab, or spray medicine to dry before covering the treated skin area.
  • Apply this medicine as often as needed (for babies, with each diaper change), unless your doctor tells you otherwise.

Proper Lantiseptic Skin Protectant (Topical) Storage

Store Lantiseptic Skin Protectant (Topical) at room temperature away from sunlight and moisture unless otherwise stated by manufacturer's instructions or labelling. Keep Lantiseptic Skin Protectant (Topical) and all medications out of the reach of children.

What To Avoid While Using Lantiseptic Skin Protectant (Topical)

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Lantiseptic Skin Protectant (Topical) Warnings

  • For adult women, make sure your doctor knows if you are pregnant or breast feeding.
  • Do not use this medicine for a skin problem that has not been checked by your doctor.
  • If someone accidentally swallows some of this medicine, call your local poison control center.
  • If rash gets worse or does not get better within 7 days, call your doctor.
  • Do not use this medicine on deep cuts or wounds or on skin that is infected.

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