Label: EAR DROPS FOR SWIMMERS- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-9103-91 - Packager: Humco Holding Group, 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.
Drug Label Information
Updated December 23, 2021
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive Ingredient
- DDM
- HEB
- CVS
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- Equate
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INGREDIENTS AND APPEARANCE
EAR DROPS FOR SWIMMERS
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9103 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:0395-9103-91 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(0395-9103) , analysis(0395-9103) , pack(0395-9103) , label(0395-9103)