Lanolin by Dynarex Corporation LANOLIN ointment

Lanolin by

Drug Labeling and Warnings

Lanolin by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient               Purpose
Lanolin USP 50%                    Skin Protectant

Purpose:

• 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

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

• If swallowed, get medical help or contact a Poison Control Center right away

Indications & 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

Dosage & Administration

• 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
  

Inactive Ingredients

Beeswax (Yellow Wax), Fragrance, HEEDTA, Lanolin alcohol, Mineral oil, Oxyguinoline, Petrolatum, Purified water, Sodium borate, Sorbitan sesquioleate

Principal Display Panel

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INGREDIENTS AND APPEARANCE

LANOLIN 
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-232
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: 67777-232-01	2 in 1 CASE
1		144 in 1 BOX
1		5 g in 1 PACKET
2	NDC: 67777-232-02	4 in 1 CASE
2		36 in 1 BOX
2		15 g in 1 PACKET
3	NDC: 67777-232-03	36 in 1 CASE
3		71 g in 1 JAR
4	NDC: 67777-232-04	24 in 1 CASE
4		113 g in 1 TUBE
5	NDC: 67777-232-05	24 in 1 CASE
5		127.5 g in 1 JAR
6	NDC: 67777-232-06	12 in 1 CASE
6		396.8 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/12/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)