ALTALUBE- mineral oil and petrolatum ointment

Altalube by

Drug Labeling and Warnings

Altalube by is a Otc medication manufactured, distributed, or labeled by Altaire Pharmaceuticals Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ActivEyes

Altalube Ointment 3.5g

NDC: 59390-198-50

Drug Facts

Active ingredients

Mineral Oil 15% and White Petrolatum 85%

Purpose

Eye Lubricant

Uses

as a lubricant to prevent further irritation   to relieve dryness of the eye(s).

Warnings

For use in the eyes only.    Save box for complete information.

When using this product

avoid contamination, do not touch tip of container to any surface.

replace cap after each use.

Stop use and ask a doctor if  

you experience eye pain, changes in vision, continued redness or irritation of the eye.  condition worsens or persists for more than 72 hours.

Keep this and all drugs out of the reach of children.

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

Directions

pull down lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid every 3-4 hours or as directed by a doctor.

Other information

store at room temperature 15°-30°C (59°-86°F). protect from freezing.

see crimp of tube or box for lot number and expiration date.

keep tightly closed.

does not contain preservatives.

Inactive Ingredients

None remove

Questions or comments?

(631) 722-5988  9AM – 5 PM EST Monday- Friday

PRINCIPAL DISPLAY PANEL

ActiEyes
Altalube Ointment
White Petrolatum
and Mineral Oil
Lubricant Eye Ointment
Preservative Free
Sterile
NET WT
3.5g (1/8 OZ)

INGREDIENTS AND APPEARANCE

ALTALUBE 
mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59390-198
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	850 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59390-198-50	1 in 1 CARTON	02/01/2002
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	02/01/2002

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Registrant - Altaire Pharmaceuticals, Inc. (786790378)