Country: United States
Language: English
Source: NLM (National Library of Medicine)
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
MIDLAB INCORPORATED
TOPICAL
OTC DRUG
OTC monograph not final
WAXIE CLEAR TONE- PCMX, HAND SOAP SOAP MIDLAB INCORPORATED _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._ ---------- PRINCIPAL DISPLAY ACTIVE INGREDIENT PCMX 0.1%. PURPOSE Antiseptic Handwashing USES Handwash to help decrease bacteria on the skin. WARNING: FOR EXTERNAL USE ONLY DO NOT USE in the eyes. In case of contact, flush thoroughly with water. STOP USE AND ASK DOCTOR IF irritation or rash appears and lasts. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse • Children under 6 years of age should be supervised when using this product. INACTIVE INGREDIENTS Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate, Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, and Red 40. WAXIE CLEAR TONE pcmx, hand soap soap PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70542-709 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 1 g in 1 L INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) PROPANEDIOL (UNII: 5965N8W85T) FD&C RED NO. 40 (UNII: WZB9127XOA) CINNAMALDEHYDE (UNII: SR60A3XG0F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EUGENOL (UNII: 3T8H1794QW) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PRODUCT CHARACTERISTICS COLOR orange (Clear) SCORE SHAPE SIZE FLAVOR IMPRINT CODE CONTAINS PACKAG Read the complete document