Label: ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol solution
- NDC Code(s): 0404-0002-01, 0404-0002-16, 0404-0002-32
- Packager: Henry Schein Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 12, 2021
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
For external use only
- keep away from fire or flame, heat, spark, electrical. Flash point 72°F
- do not use with electrocautery procedures.
When using this product
- do not get into eyes
- do not apply over large areas of the body
- do not use longer than 1 week unless directed by a doctor
- Other Information
- Inactive Ingredient
PRINCIPAL DISPLAY PANEL
Item # 112-7011
FIRST AID ANTISEPTICTamper evident cap for your protection. If ring-band
is detached from cap or missing do not use.
Distributed by (in US Only):
HENRY SCHEIN INC.
135 Duryea Road
Melville, NY 11747 USA
Rev Date: 05/14
Made in the USA
32 FL OZ • 946 mL
INGREDIENTS AND APPEARANCE
ISOPROPYL RUBBING ALCOHOL
isopropyl alcohol solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol 700 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-0002-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2014 2 NDC:0404-0002-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2014 3 NDC:0404-0002-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 06/01/2014 Labeler - Henry Schein Inc. (012430880)