Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Jurong Dongfa General Merchandise Co., Ltd.
TOPICAL
OTC DRUG
- For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination.Recommended for repeated use. ·Dries in seconds.
OTC monograph not final
HAND SANITIZING WIPES- ALCOHOL CLOTH JURONG DONGFA GENERAL MERCHANDISE CO., LTD. _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._ ---------- 75127-006 HAND SANITIZING WIPES 65.9% ALCOHOL DRUGS FACT ACTIVE INGREDIENT Alcohol 65.9% by volume PURPOSE Antiseptic USES: For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination.Recommended for repeated use. ·Dries in seconds. WARNINGS Flammable, keep away from fire or flame. For external use only.Do not use in or contact the eyes. Discontinue use if redness or irritation develops. · If condition persists for more than 72 hours, consult a physician.· Keep out of reach of children unless under adult supervision. KEEP THIS OUT OF REACH OF CHILDREN. Keep out of reach of children unless under adult supervision. DIRECTIONS Remove lid. Pull wipe from center of roll and thread through opening in lid. Do notpush finger through opening. Replace lid, pull wipe up, and then out at 45° angle. The next wipe dispenses automatically. Close lid to retain moisture. INACTIVE INGREDIENTS Water, Propylene Glycol, Glycerin,Carbomer,Aminomthyl Propanol AloeBarbadenis Leaf Juice,Tocopheryl Acetate. PACKAGE LABELING: HAND SANITIZING WIPES alcohol cloth PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:75127-006 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.659 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING STA Read the complete document