Label: DISPOSABLE DISINFECTANT gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76680-007-01, 76680-007-02, 76680-007-03, 76680-007-04, view more76680-007-05, 76680-007-06, 76680-007-07, 76680-007-08, 76680-007-09, 76680-007-10, 76680-007-11, 76680-007-12, 76680-007-13 - Packager: Guangzhou Saimei Pharmaceutical Co., Ltd
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DISPOSABLE DISINFECTANT
disposable disinfectant gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76680-007 Route of Administration TOPICAL, CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.2 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL in 100 mL CARBOMER COPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1N11AG4X4L) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) 22.8 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76680-007-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:76680-007-02 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:76680-007-03 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:76680-007-04 80 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 5 NDC:76680-007-05 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 6 NDC:76680-007-06 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 7 NDC:76680-007-07 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 8 NDC:76680-007-08 350 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 9 NDC:76680-007-09 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 10 NDC:76680-007-10 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 11 NDC:76680-007-11 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 12 NDC:76680-007-12 700 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 13 NDC:76680-007-13 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/14/2020 Labeler - Guangzhou Saimei Pharmaceutical Co., Ltd (403429980) Establishment Name Address ID/FEI Business Operations Guangzhou Saimei Pharmaceutical Co., Ltd 403429980 manufacture(76680-007)
