STYE- mineral oil and petrolatum gel

Stye by

Drug Labeling and Warnings

Stye by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

STYE- mineral oil and petrolatum gel
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Stye™
Sterile Lubricant
Eye Ointment

Drug Facts

Active ingredients

Mineral oil 31.9%

Purpose

Emollient

Active ingredients

White petrolatum 57.7%

Purpose

Emollient

Uses

• temporarily relieves burning and irritation of the eye
  
• as a lubricant to prevent further irritation of the eye

Warnings

For external use only

When using this product

• to avoid contamination do not touch tip of container to any surface
  
• replace cap after use

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

• pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid

Other information

Do not use if cap neck-seal is cut, broken, or missing.

• Keep carton for full drug facts.

Inactive Ingredients

microcrystalline wax, stearic acid, wheat germ oil

Questions?

call 1-800-344-7239

Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

CLINICALLY PROVEN SYMPTOMATIC RELIEF

Temporarily relieves discomfort due to minor irritations including:

• Burning
  
• Stinging
  
• Itching

PRINCIPAL DISPLAY PANEL

Ophthalmologist
Tested
Stye™
Sterile Lubricant
Eye Ointment
NET WT. 0.125 OZ (3.5g)
SAFETY SEALED CAP

INGREDIENTS AND APPEARANCE

STYE 
mineral oil and petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-238
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	319 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	577 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHEAT GERM OIL (UNII: 14C97E680P)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-238-24	24 in 1 CASE	06/15/2010
1		1 in 1 BOX
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	06/15/2010

Labeler - Insight Pharmaceuticals LLC (055665422)