Label: HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74658-010-01, 74658-010-02, 74658-010-03, 74658-010-04, view more74658-010-05, 74658-010-06, 74658-010-07, 74658-010-08, 74658-010-09 - Packager: GUANGZHOU XUELEI COSMETIC 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 November 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable. Keep away from fire or flame. Do not store in car.
Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately
Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.
If irritation develops, discontinue use and consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74658-010 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 WATER (UNII: 059QF0KO0R) 22.1937 g in 100 mL TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.0809 g in 100 mL CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) 0.4 g in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.22 g in 100 mL DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O) 0.0004 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74658-010-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 2 NDC:74658-010-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 3 NDC:74658-010-03 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 4 NDC:74658-010-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 5 NDC:74658-010-05 260 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 6 NDC:74658-010-06 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 7 NDC:74658-010-07 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/02/2020 8 NDC:74658-010-08 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/02/2020 9 NDC:74658-010-09 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/02/2020 Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026) Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026) Establishment Name Address ID/FEI Business Operations GUANGZHOU XUELEI COSMETIC CO.,LTD. 526885026 manufacture(74658-010) , pack(74658-010) , label(74658-010)