Label: HYGIENIGEL- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78619-200-02, 78619-200-03, 78619-200-04, 78619-200-05, view more78619-200-06, 78619-200-07, 78619-200-08 - Packager: HAIKOWER S.r.l.
- 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 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Dosage and Admin
- Inactive ingredients
- Active Ingredient
- OTC - Ask Doctor
- OTC - Do not use
- OTC - Keep out of children
- OTC - Purpose
- OTC - Stop use
- Warnings
- Indication and USage
- Label
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INGREDIENTS AND APPEARANCE
HYGIENIGEL
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78619-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) LANOLIN (UNII: 7EV65EAW6H) TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER 1342 (UNII: 809Y72KV36) FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) PANTHENOL (UNII: WV9CM0O67Z) PEG/PPG-14/4 DIMETHICONE (UNII: 646XNV22YX) PROPYLENE GLYCOL 1-LAURATE (UNII: M4AW13H75T) DMDM HYDANTOIN (UNII: BYR0546TOW) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78619-200-07 5000 mL in 1 CAN; Type 0: Not a Combination Product 02/25/2021 2 NDC:78619-200-06 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2021 3 NDC:78619-200-05 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2021 4 NDC:78619-200-04 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2021 5 NDC:78619-200-03 70 mL in 1 POUCH; Type 0: Not a Combination Product 02/25/2021 6 NDC:78619-200-02 30 mL in 1 POUCH; Type 0: Not a Combination Product 02/25/2021 7 NDC:78619-200-08 2 mL in 1 POUCH; Type 0: Not a Combination Product 02/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/25/2021 Labeler - HAIKOWER S.r.l. (433503760) Registrant - MELCHIONNA PLLC (039407173) Establishment Name Address ID/FEI Business Operations HAIKOWER S.r.l. 433503760 manufacture(78619-200) , label(78619-200) , pack(78619-200)
