Label: HUMCO EAR DROPS FOR SWIMMERS- isopropyl alcohol liquid
- NDC Code(s): 0395-0098-91
- 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 March 16, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
Flammable: Keep away from fire and flame.
Ask a doctor before use if you have
Ear drainage or discharge.
Pain, irritation, or rash in the ear.
Have had ear surgery.
- Other information
- Inactive Ingredient
- Principal Display Panel
INGREDIENTS AND APPEARANCE
HUMCO EAR DROPS FOR SWIMMERS
isopropyl alcohol liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-0098 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:0395-0098-91 1 in 1 CARTON 01/01/2008 1 30 mL in 1 BOTTLE, PLASTIC; 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 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-0098) , analysis(0395-0098) , pack(0395-0098) , label(0395-0098)