Label: ADVANCED HYGIENIC HAND SANITIZER- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75484-005-50 - Packager: SYNERGYPLANETS INC.
- 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 28, 2020
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- Active Ingredient
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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- Inactive Ingredients
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- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ADVANCED HYGIENIC HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75484-005 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 TROLAMINE (UNII: 9O3K93S3TK) LEVOMENTHOL (UNII: BZ1R15MTK7) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75484-005-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/30/2020 Labeler - SYNERGYPLANETS INC. (695720324) Registrant - SYNERGYPLANETS INC. (695720324) Establishment Name Address ID/FEI Business Operations Farmer's grain korea 694439983 manufacture(75484-005) Establishment Name Address ID/FEI Business Operations ICOMAX Co., Ltd. 694834031 manufacture(75484-005)