Label: REFRESH P.M.- mineral oil, petrolatum ointment
- NDC Code(s): 0023-0240-04, 0023-0240-21
- Packager: Allergan, 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 August 17, 2014
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- Active ingredients
For external use only.
To avoid contamination, do not touch tip of container to any surface.
- Replace cap after using.
Stop use and ask a doctor if you
experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
- For external use only.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
mineral oil, petrolatum ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-0240 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength mineral oil (UNII: T5L8T28FGP) (mineral oil - UNII:T5L8T28FGP) mineral oil 425 mg in 1 g petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum 573 mg in 1 g Inactive Ingredients Ingredient Name Strength lanolin alcohols (UNII: 884C3FA9HE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0023-0240-21 1 in 1 CARTON 04/23/1990 1 3.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0023-0240-04 1 in 1 CARTON 04/23/1990 2 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 04/23/1990 Labeler - Allergan, Inc. (144796497)