Label: CROSSCO- isopropyl alcohol solution
- NDC Code(s): 74213-382-04, 74213-382-08, 74213-382-10, 74213-382-17
- Packager: Max Chemical, 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.
Drug Label Information
Updated April 20, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use
- in children less than 2 months of age
- on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
- irritation and redness develop
- condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
CROSSCO
isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74213-382 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74213-382-08 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2020 2 NDC:74213-382-10 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2020 3 NDC:74213-382-17 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2020 4 NDC:74213-382-04 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/17/2020 Labeler - Max Chemical, Inc. (118159136) Establishment Name Address ID/FEI Business Operations Max Chemical, Inc. 118159136 manufacture(74213-382)
