Label: KLEENFOAM- otc antimicrobial drug product aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-093-34 - Packager: Dermarite Industries 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 January 17, 2020
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose:
- Uses:
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Warnings:
- For external use only.
- Avoid contact with eyes. In case of contact, flush thoroughly with water.
- Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns
- When using this product, do not apply to areas of raw or blistered skin in large quantities, do not use in or near the eyes
- Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days or clear up and recur within a few days
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Warnings:
For external use only.
Avoid contact with eyes. In case of contact, flush thoroughly with water.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away
- Directions:
- Other information:
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Inactive Ingredients:
Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Polysorbate 20, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Disodium EDTA, Sodium Isostearoyl lactylate, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide
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- Kleenfoam Package Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
KLEENFOAM
otc antimicrobial drug product aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61924-093 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) LEMON OIL (UNII: I9GRO824LL) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO MONOETHANOLAMIDE (UNII: C80684146D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61924-093-34 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 12/12/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/12/2011 Labeler - Dermarite Industries LLC (883925562) Registrant - Dermarite Industries LLC (883925562) Establishment Name Address ID/FEI Business Operations Dermarite Industries LLC 883925562 manufacture(61924-093)
