Label: M. SKIN CARE GEL HAND SANITIZER- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77218-002-01 - Packager: Palm Beach Beaute, LLC
- 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 April 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aqua, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Jojoba Wax PEG-120 Esters, Aloe Barbadensis Leaf Extract, Citric Acid, Sodium Benzoate, Potassium Sorbate, Sodium Sulfite, CI 60730, CI 17200, ISO E SUPER, HEDIONE, DIPROPYLENE GLYCOL, GALAXOLIDE, ETHYLENE BRASSILATE.
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
1.Flammable, keep away from fire or fame.
2.For external use only
3.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
4.Stop use and ask a doctor if redness or iritation or rash appears and persists for more than 72 hours.
5.Keep out of reach of children. If swallowed, get medical help or contact the Poison Control center right away. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
M. SKIN CARE GEL HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77218-002 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 262.5 mL in 350 mL Inactive Ingredients Ingredient Name Strength SODIUM SULFITE (UNII: VTK01UQK3G) DIPROPYLENE GLYCOL (UNII: E107L85C40) D&C RED NO. 33 (UNII: 9DBA0SBB0L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) 1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77218-002-01 350 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/24/2020 Labeler - Palm Beach Beaute, LLC (007721815) Establishment Name Address ID/FEI Business Operations Palm Beach Beaute, LLC 007721815 manufacture(77218-002)