LANOLIN- lanolin ointment 
Sion Biotext Medical Ltd

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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Lantisepton 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

Indications and Usage

  • 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

Inactive Ingredient


Inactive Ingredients: Beeswax, Fragrance, HEEDTA, Lanolin alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified water, Sodium borate, Sesquioleate


Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

Principal Display Panel

Sion Biotext Medical Ltd

LANTISEPTON OINTMENT

SKIN BARRIER

FOR INCONTINENCE DIAPER DERMATITIS, CHAFED OR ULCER PRONE SKIN

NET WT. 4 oz (113.6 g)

Label

LANOLIN 
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-232
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
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PETROLATUM (UNII: 4T6H12BN9U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
MINERAL OIL (UNII: T5L8T28FGP)  
OXYQUINOLINE (UNII: 5UTX5635HP)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-232-012 in 1 CASE07/09/201212/31/2022
1144 in 1 BOX
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:68786-232-024 in 1 CASE07/09/201212/31/2022
236 in 1 BOX
215 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:68786-232-0336 in 1 CASE07/09/201212/31/2022
371 g in 1 JAR; Type 0: Not a Combination Product
4NDC:68786-232-0424 in 1 CASE07/09/201212/31/2022
4114 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:68786-232-0524 in 1 CASE07/09/201212/31/2022
571 g in 1 JAR; Type 0: Not a Combination Product
6NDC:68786-232-0612 in 1 CASE07/09/201212/31/2022
6396.8 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/09/201212/31/2022
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(68786-232)

Revised: 12/2022
Document Id: efe1a0f9-ed16-54d7-e053-2a95a90afb80
Set id: 115af0c8-a6fa-4d8e-9b22-9912d7fbc9ba
Version: 4
Effective Time: 20221215
 
Sion Biotext Medical Ltd