Label: PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61577-1118-4, 61577-1118-6, 61577-1118-8 - 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 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Other Information
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Inactive ingredients
Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel
Oil, Citrus Limon (Lemon) Peel Oil, Filipendula Ulmaria, (Queen of the Prairie) Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Yucca Schidigera Stem Extract - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-1118 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) ORANGE PEEL (UNII: TI9T76XD44) CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED) FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN) GLYCERIN (UNII: PDC6A3C0OX) WITCH HAZEL (UNII: 101I4J0U34) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-1118-8 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/16/2020 2 NDC:61577-1118-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/16/2020 3 NDC:61577-1118-6 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/16/2020 Labeler - SOMBRA COSMETICS (097464309) Establishment Name Address ID/FEI Business Operations SOMBRA COSMETICS 097464309 manufacture(61577-1118) , label(61577-1118)
