Label: SWIM-EAR solution
- NDC Code(s): 0168-0126-91
- Packager: Fougera 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 March 29, 2021
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- Drug Facts
- Active ingredient
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you have
- ear drainage or discharge
- pain, irritation or rash in ear
- had ear surgery
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0126 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 950 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0126-91 1 in 1 CARTON 04/03/1970 1 29.57 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 04/03/1970 Labeler - Fougera Pharmaceuticals Inc. (043838424)