Label: ADVANCED HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81477-101-01, 81477-101-02, 81477-101-03, 81477-101-04, view more81477-101-05, 81477-101-06, 81477-101-07, 81477-101-08, 81477-101-09, 81477-101-10 - Packager: SHENZHEN HYDROXY TECHNOLOGY 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 February 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81477-101 Route of Administration TOPICAL 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 GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CHLOROXYLENOL (UNII: 0F32U78V2Q) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81477-101-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 2 NDC:81477-101-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 3 NDC:81477-101-03 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 4 NDC:81477-101-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 5 NDC:81477-101-05 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 6 NDC:81477-101-06 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 7 NDC:81477-101-07 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 8 NDC:81477-101-08 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 9 NDC:81477-101-09 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 10 NDC:81477-101-10 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/01/2021 Labeler - SHENZHEN HYDROXY TECHNOLOGY CO.,LTD (552726183) Establishment Name Address ID/FEI Business Operations SHENZHEN HYDROXY TECHNOLOGY CO.,LTD 552726183 manufacture(81477-101)