Label: SUDESAN HAND SANITIZER ORIGINAL- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 75112-002-01, 75112-002-02, 75112-002-03, 75112-002-04, view more75112-002-05, 75112-002-06, 75112-002-07, 75112-002-08 - Packager: Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch
- 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 22, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUDESAN HAND SANITIZER ORIGINAL
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75112-002 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 GLYCEROL FORMAL (UNII: 3L7GR2604E) CARBOMER 934 (UNII: Z135WT9208) TROLAMINE (UNII: 9O3K93S3TK) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75112-002-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 2 NDC:75112-002-02 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 3 NDC:75112-002-03 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 4 NDC:75112-002-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 5 NDC:75112-002-05 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 6 NDC:75112-002-06 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 7 NDC:75112-002-07 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 8 NDC:75112-002-08 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/10/2020 Labeler - Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch (414137820) Establishment Name Address ID/FEI Business Operations Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch 414137820 manufacture(75112-002)
