Label: HAND SANITIZER AGAVESPA SKINCARE- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77415-000-00 - Packager: DDI Multinacional, S.A. de C.V.
- 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 8, 2020
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Inactive Ingredients
Water, agave tequilana weber (blue agave) extract, aloe barbadensis (aloe vera) extract, aloe barbadensis (aloe vera) extract, triethanolamine, carbomer, citrus nobilis (mandarin) essential oil, citrus tangerina (tangerine) essential oil, citrus aurantifolia (mexica lime) essential oil, citrus grandis (grapefruit) essential oil, glycerin, caprylys glycol, decylene glycol, benzoic acid, carmine.
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INGREDIENTS AND APPEARANCE
HAND SANITIZER AGAVESPA SKINCARE
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77415-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AGAVE TEQUILANA LEAF (UNII: 05545M0E3M) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) MANDARIN OIL (UNII: NJO720F72R) LIME OIL (UNII: UZH29XGA8G) GRAPEFRUIT OIL (UNII: YR377U58W9) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DECYLENE GLYCOL (UNII: S57M60MI88) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77415-000-00 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/01/2020 Labeler - DDI Multinacional, S.A. de C.V. (812776741)