Label: CLEAN IS IN HAND SANITIZER ANTISEPTIC FOAM- hand sanitizer antiseptic foam aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 80473-030-01 - Packager: Beauty-Lab 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 September 10, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Warnings
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Contents under pressure.
•Do not puncture or incinerate.
•Do not store above 104°F (40°C)
When using this product
•Avoid contact with eyes.If contact occurs, rinse immediately
and thoroughly with water.
•Do not use on children under 2 months of age.
•Do not use on open wounds.
•Discontinue use if irritation/redness occurs.
Stop use and ask a doctor if irritation occurs. This may be
a sign of a serious condition.
Keep out of reach of children. •In case of ingestion, get
medical help or contact a Poison Control Center immediately. - Inactive Ingredients
- Active Ingredients
- Purpose
- Keep out of Reach
- Uses
- Dosage
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Warnings
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Contents under pressure.
•Do not puncture or incinerate.
•Do not store above 104°F (40°C)
When using this product
•Avoid contact with eyes.If contact occurs, rinse immediately
and thoroughly with water.
•Do not use on children under 2 months of age.
•Do not use on open wounds.
•Discontinue use if irritation/redness occurs.
Stop use and ask a doctor if irritation occurs. This may be
a sign of a serious condition.
Keep out of reach of children. •In case of ingestion, get
medical help or contact a Poison Control Center immediately. - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAN IS IN HAND SANITIZER ANTISEPTIC FOAM
hand sanitizer antiseptic foam aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80473-030 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0) Isobutane (UNII: BXR49TP611) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Polysorbate 60 (UNII: CAL22UVI4M) Cetyl Lactate (UNII: A7EVH2RK4O) Steareth-2 (UNII: V56DFE46J5) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Sesquicarbonate (UNII: Y1X815621J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80473-030-01 200 g in 1 CONTAINER; Type 0: Not a Combination Product 09/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/10/2020 Labeler - Beauty-Lab LLC (053878473) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. (DBA KIK Custom Products) 024213616 manufacture(80473-030)
