Label: PURE AND SAFE HAND SANITIZER PLUS GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77123-201-01 - Packager: COSCOS 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 14, 2020
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- Official Label (Printer Friendly)
- Active ingredient[s]
- Purpose
- Use[s]
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
PURE AND SAFE HAND SANITIZER PLUS GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77123-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77123-201-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/12/2020 Labeler - COSCOS LLC (122642799) Registrant - COSCOS LLC (122642799) Establishment Name Address ID/FEI Business Operations COSCOS LLC 122642799 label(77123-201) Establishment Name Address ID/FEI Business Operations WHAIN COSMETIC 557837595 manufacture(77123-201)