Label: ALCOHOL-BASED DISINFECTANT HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74757-002-01, 74757-002-02, 74757-002-03, 74757-002-04, view more74757-002-05, 74757-002-06, 74757-002-07, 74757-002-08, 74757-002-09, 74757-002-10, 74757-002-11, 74757-002-12, 74757-002-13 - Packager: GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT 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 21, 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
- 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
- USE
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALCOHOL-BASED DISINFECTANT HAND SANITIZER
alcohol-based disinfectant hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74757-002 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 CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74757-002-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:74757-002-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:74757-002-02 330 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:74757-002-04 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:74757-002-05 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:74757-002-06 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 7 NDC:74757-002-07 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 8 NDC:74757-002-08 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 9 NDC:74757-002-09 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 10 NDC:74757-002-10 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 11 NDC:74757-002-11 3000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 12 NDC:74757-002-12 4000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 13 NDC:74757-002-13 5000 mL in 1 BOTTLE; 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 03/20/2020 Labeler - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476) Registrant - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476) Establishment Name Address ID/FEI Business Operations GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD 540725476 manufacture(74757-002)