Label: ALOE VERA CENTER HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61577-1113-2, 61577-1113-4, 61577-1113-8 - Packager: SOMBRA COSMETICS
- 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 July 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- Do not use
- When Using
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
glycerin, aloe barbadensis leaf extract, camellia sinensis (green tea) leaf extract, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, citrus aurantium dulcis (orange) peel oil, filipendula ulmaria (queen of the prairie) extract, yucca schidigera root extract
- Purpose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE VERA CENTER HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-1113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) WITCH HAZEL (UNII: 101I4J0U34) ORANGE OIL (UNII: AKN3KSD11B) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-1113-8 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/2020 2 NDC:61577-1113-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/2020 3 NDC:61577-1113-2 54 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 Labeler - SOMBRA COSMETICS (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS 097464309 manufacture(61577-1113)