Label: AMERICAN SHAMAN HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77551-001-01, 77551-001-04, 77551-001-08, 77551-001-11 - Packager: Cbd American Shaman, LLC
- Category: HUMAN OTC DRUG LABEL
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 June 25, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients [s]
- Purpose
- Use[s]
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
- in children less than 2 months of age
- on open skin wounds
When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. - Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
AMERICAN SHAMAN HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77551-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) POWDERED CELLULOSE (UNII: SMD1X3XO9M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77551-001-01 29 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 2 NDC:77551-001-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 3 NDC:77551-001-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 4 NDC:77551-001-11 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/11/2020 Labeler - Cbd American Shaman, LLC (085803529) Establishment Name Address ID/FEI Business Operations Cbd American Shaman, LLC 085803529 manufacture(77551-001)