Your browser does not support JavaScript! LANTISEPTIC SKIN PROTECTANT (LANOLIN) CREAM [SUMMIT INDUSTRIES, INC.]
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LANTISEPTIC SKIN PROTECTANT (lanolin) cream
[Summit Industries, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

  • Helps prevent and treat diaper dermatitis.
  • Protects chafed skin or minor skin irritations due to incontinence and 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 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

SP400g.jpgSkin Protectant Label 400 grams

SP_130.jpg image description

LANTISEPTIC  SKIN PROTECTANT
lanolin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID 
LANOLIN ALCOHOLS 
MINERAL OIL 
OXYQUINOLINE 
PETROLATUM 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-0019-65 g in 1 PACKET
2NDC:12090-0019-114.2 g in 1 JAR
3NDC:12090-0019-270 g in 1 TUBE
4NDC:12090-0019-3113 g in 1 JAR
5NDC:12090-0019-4130 g in 1 JAR
6NDC:12090-0019-5400 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/FEIBusiness Operations
Summit Industries, Inc.003279189manufacture(12090-0019)

Revised: 1/2013
 
Summit Industries, Inc.

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