Label: SIMPLE SANITIZER- isopropyl alcohol gel
SIMPLE SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 75333-001-01, 75333-001-02, 75333-002-01, 75333-002-02 - Packager: Compass Coffee Llc
- 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 May 5, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry. The hand sanitizer is manufactured consistent with World Health Organization (WHO) formulation II.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- Discontinue Use
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SIMPLE SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75333-002 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 HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.4 mL in 100 mL WATER (UNII: 059QF0KO0R) 26 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.725 mL in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.1 mL in 100 mL 2,4,5-T-TROLAMINE (UNII: 9007L1DAXM) 0.2 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75333-002-01 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/08/2020 2 NDC:75333-002-02 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/08/2020 SIMPLE SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75333-001 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 GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.725 mL in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.1 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75333-001-01 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 2 NDC:75333-001-02 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Compass Coffee Llc (079255636) Registrant - Compass Coffee Llc (079255636) Establishment Name Address ID/FEI Business Operations Union Kitchen Llc 079235761 manufacture(75333-001, 75333-002) , pack(75333-001, 75333-002) , label(75333-001, 75333-002)
