STYE- mineral oil and petrolatum gel 
Insight Pharmaceuticals LLC

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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Stye

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

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

Other information

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

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:

PRINCIPAL DISPLAY PANEL

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

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

STYE 
mineral oil and petrolatum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-238
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL319 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM577 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WHEAT GERM OIL (UNII: 14C97E680P)  
Product Characteristics
ColorWHITE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-238-2424 in 1 CASE06/15/2010
11 in 1 BOX
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/15/2010
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 10/2019
Document Id: 9e44e7b8-edc5-4f32-a696-30c4acb76e42
Set id: f7eb8466-d8ea-4833-9bed-244ead38a3bf
Version: 3
Effective Time: 20191018
 
Insight Pharmaceuticals LLC