Label: HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 51706-911-01
- Packager: Landy International
- 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 March 21, 2022
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
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Warnings
For external use only : hands
Flammable, keep away from fire or flame.
When using this product
■keep out of eyes. In case of contact with
eyes flush thoroughly with water .■ avoid contact with broken skin ■ do not inhale or ingest
Stop use and ask doctor if irritation and redness develop condition persists for more than 72 hours - KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-911 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 DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51706-911-01 325 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/15/2020 Labeler - Landy International (545291775) Registrant - Landy International (545291775) Establishment Name Address ID/FEI Business Operations Landy International 545291775 manufacture(51706-911)