Lanolin by Sion Biotext Medical Ltd LANOLIN ointment

Lanolin by

Drug Labeling and Warnings

Lanolin by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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
  

WARNINGS

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)

INGREDIENTS AND APPEARANCE

LANOLIN 
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-232-01	2 in 1 CASE	07/09/2012
1		144 in 1 BOX
1		5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68786-232-02	4 in 1 CASE	07/09/2012
2		36 in 1 BOX
2		15 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 68786-232-03	36 in 1 CASE	07/09/2012
3		71 g in 1 JAR; Type 0: Not a Combination Product
4	NDC: 68786-232-04	24 in 1 CASE	07/09/2012
4		114 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 68786-232-05	24 in 1 CASE	07/09/2012
5		71 g in 1 JAR; Type 0: Not a Combination Product
6	NDC: 68786-232-06	12 in 1 CASE	07/09/2012
6		396.8 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/09/2012

Labeler - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-232)