Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Shalom International Corp
TOPICAL
OTC DRUG
To decrease bacteria on the skin and clean hands. Recommended for repeated use.
OTC monograph not final
SPATHERAPY ANTI-BACTERIAL HAND EUCALYPTUS MINT- ALCOHOL GEL SHALOM INTERNATIONAL CORP _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._ ---------- SPATHERAPY ANTI-BACTERIAL HAND GEL EUCALYPTUS MINT DRUG FACTS ACTIVE INGREDIENT Alcohol Denat 60% w/w PURPOS E Antibacterial US E To decrease bacteria on the skin and clean hands. Recommended for repeated use. WARNINGS For external use only. Flammable, keep away from fire or flame. KEEP OUT OF REACH OF CHILDREN. For external use only. Flammable, keep away from fire or flame. DO NOT GET INTO EYE. If contact occurs, rinse thoroughly with water. DISCONTINUE USE if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor. DIRECTIONS Apply to hands until thoroughly wet. Rubvigorously until dry. INACTIVE INGREDIENTS Water(Aqua), PEG-40 Hydrogenated Caster Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance(Parfum), Sodium Hydroxide, Tocopheryl Acetate, Simmndsia Chinensis (jojoba) Seed Wax, FD&C Blue 1(CI 42090), FD&C Yellow 5(CI 19140), D&C Red 33(CI 17200) PACKAGE LABELING: SPATHERAPY ANTI-BACTERIAL HAND EUCALYPTUS MINT alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:730 25-0 40 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 0 .6 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F) CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) Shalom International Corp SIMMO NDSIA CHINENSIS SEED WAX (UNII: 47X6 Y9 FJJ2) FD&C BLUE NO . 1 (UNII: H3R47K3TBD) FD&C YELLO W NO . 5 (UNII: I753WB2F1M Perskaitykite visą dokumentą