Drug Labeling and Warnings

Drug Details

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LUBRICANT STYE- mineral oil, white petrolatum ointment ointment 
AACE PHARMACEUTICALS, INC.

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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SPL UNCLASSIFIED SECTION

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.

ACTIVE INGREDIENTS

Mineral Oil 31.9% and White Petrolatum 57.7%

PURPOSE

Emollient

USES

  • for the temporary relief of discomfort due to minor irritations.

WARNINGS

When using this product

  • 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.
  • the 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 immediately.

KEEP OUT OF REACH OF CHILDREN

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

OTHER INFORMATION

  • store at room temperature 15°-30°C (59°-86°F).

  • see the crimp of tube or box for Lot Number and Expiration Date.

  • Use only if tape seals on top and bottom flaps are intact.

  • Do not use if bottom ridge of the tube cap is exposed.

INACTIVE INGREDIENTS

Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

PRINCIPAL DISPLAY PANEL

NDC#: 71406-125-35

Compare to Stye TM Active ingredients*

Lubricant Stye Ointment

Temporarily relieves discomfort due to itching, burning, stinging & other minor irritations

Not a cure for infection

Preservative-free

Net Wt. 0.125 oz (3.5 g) Sterile

Distributed By:

AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

www. aacepharma.com

Rev. 00

This product is not manufactured or distributed by Insight Pharmaceutical Corp., owner of the registered trademark Stye TM

Stye Ointment

LUBRICANT STYE 
mineral oil, white petrolatum ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71406-125
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
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71406-125-351 in 1 CARTON03/19/2020
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/19/2020
Labeler - AACE PHARMACEUTICALS, INC. (080630748)
Establishment
NameAddressID/FEIBusiness Operations
Brassica Pharma Limited675476593manufacture(71406-125)

Revised: 3/2020
 
AACE PHARMACEUTICALS, INC.


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