Label: COTTONWOOD SANITIZER GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78002-101-01, 78002-101-02, 78002-101-03, 78002-101-04 - Packager: Alpine Distilling
- 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 July 6, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s):
- Purpose :
- Use(s):
- Warning:
- Directions:
- Other Information:
- Inactive Ingredients:
- Principal Display Panel – 500 mL Bottle Label
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INGREDIENTS AND APPEARANCE
COTTONWOOD SANITIZER GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78002-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Betaine (UNII: 3SCV180C9W) Polyacrylamide (Crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) (UNII: RHA9LWJ494) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) Laureth-7 (UNII: Z95S6G8201) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78002-101-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2020 2 NDC:78002-101-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2020 3 NDC:78002-101-03 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2020 4 NDC:78002-101-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/06/2020 Labeler - Alpine Distilling (080985574) Establishment Name Address ID/FEI Business Operations Alpine Distilling 080985574 MANUFACTURE(78002-101)