LANOLIN - lanolin ointment 
Dynarex Corporation

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.

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Lanashield Ointment

Active ingredient               Purpose           
Lanolin USP 50%                    Skin Protectant

Uses:

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

For External Use Only

Warnings and Precautions

  • 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

Directions:

  • Gently cleanse and dry area
  • Apply liberally to affected area as needed

Other information:

  • Store at room temperature 20 deg C to 25 deg C 68 deg F to 77 deg F

Principal Display Panel

LanolinEnter section text here

LANOLIN 
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-232
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (LANOLIN) LANOLIN50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITAN SESQUIOLEATE 
PETROLATUM 
YELLOW WAX 
LANOLIN ALCOHOLS 
MINERAL OIL 
OXYQUINOLINE 
SODIUM BORATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-232-012 in 1 CASE
1144 in 1 BOX
15 g in 1 PACKET
2NDC:67777-232-024 in 1 CASE
236 in 1 BOX
215 g in 1 PACKET
3NDC:67777-232-0336 in 1 CASE
371 g in 1 JAR
4NDC:67777-232-0424 in 1 CASE
4113 g in 1 TUBE
5NDC:67777-232-0524 in 1 CASE
5127.5 g in 1 JAR
6NDC:67777-232-0612 in 1 CASE
6396.8 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/12/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma India Private Limited918531450manufacture
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture

Revised: 5/2010
Document Id: 30267047-15ec-4bc5-b5d8-5a6196d09927
Set id: 87216888-1753-4fd5-a8e0-d8347948b082
Version: 1
Effective Time: 20100512
 
Dynarex Corporation