LANASHIELD- 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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1263

Active Ingredient

Lanolin 50%

Purpose

Skin Protectant

Uses

Warnings

For External Use Only

Do Not Use On

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

When Using This Product

  • Avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Apply as needed

Other Information

Inactive Ingredients

Beeswax (White), EDTA, Emulsifying Wax, Lanolin Alcohol, Mineral Oil, Mint Perfume,Petrolatum, Purified Water, Sodium Borate

Label

1263 IN MASTER1263 LanaShield Skin Protectant

LANASHIELD 
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-410-0324 in 1 CASE10/12/2014
1NDC:67777-410-04113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/12/2014
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 11/2022
Document Id: ee135f91-fc87-3b20-e053-2995a90a3db8
Set id: 94b277dc-6512-4d36-8485-8ea510097428
Version: 6
Effective Time: 20221122
 
Dynarex Corporation