Label: KLEAN 4 IN 1 SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 82122-002-01 - Packager: DepilatoCosmetics SAS
- 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 December 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
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INGREDIENTS AND APPEARANCE
KLEAN 4 IN 1 SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82122-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 430 g in 500 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 1.75 g in 500 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.40 g in 500 g WATER (UNII: 059QF0KO0R) 61.83 g in 500 g METHYL GLUCETH-20 (UNII: J3QD0LD11P) 1.25 g in 500 g POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E) 1.25 g in 500 g AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.527 g in 500 g 2-AMINO-1-BUTANOL (UNII: N008Q02GPS) 0.003 g in 500 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82122-002-01 500 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/14/2021 Labeler - DepilatoCosmetics SAS (275215360) Establishment Name Address ID/FEI Business Operations DepilatoCosmetics SAS 275215360 manufacture(82122-002)