Label: KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT- alcohol gel
KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75498-275-16, 75498-375-16 - Packager: THE DOJO, 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 June 12, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
The hand sanitizer is manufactured using the following ingredients:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerine
- Trolamine
- Sterile distilled water or boiled cold water.
- Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%)
- Lemongrass Oil
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
- 500 mL NDC: NDC 75498-375-16
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INGREDIENTS AND APPEARANCE
KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75498-275 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75498-275-16 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/12/2020 KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75498-375 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75498-375-16 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/12/2020 Labeler - THE DOJO, LLC (030972745) Establishment Name Address ID/FEI Business Operations THE DOJO, LLC 030972745 manufacture(75498-275, 75498-375)
