Label: EQUATE LUBRICANT STYE- mineral oil, white petrolatum ointment
- 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 February 12, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
• For use in the eye(s) only.
• Retain outer carton for full product drug facts.
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 for persists for more than 72 hours.
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EQUATE LUBRICANT STYE
mineral oil, white petrolatum ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-879 Route of Administration TOPICAL 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-879-50 1 in 1 CARTON 05/12/2017 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 05/12/2017 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Altaire Pharmaceuticals, Inc. (786790378)