Label: ALOE VERA HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 67984-004-01 - Packager: XIAMEN EASEPAL ENTERPRISES LIMITED
- 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 30, 2020
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from heat or flame Do not use in cildren less than2 months of age .on open skin woundsWhen using this product keep out of eye,ears, and mouth. In case of contat with eyes, rinse thoroughly with water.
Stop use and ask a doctor if itationo or rash ocus. These moy be signs of a senious condition.Keep gut of reach of children. If sollowed, get medical help or contorl Poison Control Center right away. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE VERA HAND SANITIZER
aloe vera hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67984-004 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 307.45 mL in 473 mL Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 4 (UNII: X3W0AM1JLX) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67984-004-01 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/29/2020 Labeler - XIAMEN EASEPAL ENTERPRISES LIMITED (679849096) Establishment Name Address ID/FEI Business Operations XIAMEN EASEPAL ENTERPRISES LIMITED 679849096 manufacture(67984-004)