Label: LUBRICANT STYE- mineral oil, white petrolatum ointment ointment
- NDC Code(s): 71406-125-35
- Packager: AACE PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 26, 2022
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL
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
Net Wt. 0.125 oz (3.5 g) Sterile
AACE Pharmaceuticals, Inc., Fairfield, NJ 07004
This product is not manufactured or distributed by Insight Pharmaceutical Corp., owner of the registered trademark Stye TM
INGREDIENTS AND APPEARANCE
mineral oil, white petrolatum ointment ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71406-125 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71406-125-35 1 in 1 CARTON 03/19/2020 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 03/19/2020 Labeler - AACE PHARMACEUTICALS, INC. (080630748)