Label: KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74025-444-90 - Packager: CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY
- 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 7, 2020
If you are a consumer or patient please visit this version.
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings Flammable, keep away from fire/flame
For external use
Do not use • in children less than 2 months of age • on open skin
When using this product get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours
- DOSAGE & ADMINISTRATION
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- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
KLEANER For A Healthier Life
ANTIBACTERIAL
TEA TREE SCENT
hand crafted in small batches designed for daily use
Distributed by:
Chiavaye LLC
Denver, CO 80209
kleanhandsanitizer.com
Customer Service:
support@kleanhandsanitizer.com
Manufactured for: Klean + Hand Sanitizer, PO Box 9751 225 S Broadway, Denver, CO 80209
Made in Vietnam
- Packaging
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INGREDIENTS AND APPEARANCE
KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74025-444 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) COCONUT OIL (UNII: Q9L0O73W7L) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74025-444-90 90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/06/2020 Labeler - CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY (556673620) Establishment Name Address ID/FEI Business Operations CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY 556673620 manufacture(74025-444)