Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Active Ingredients: Benzalkonium Chloride - 0.13%, Antimicrobial
Health-Tech, Inc.
TOPICAL
OTC DRUG
For hand sanitizing to decrease bacteria on skin
OTC monograph not final
CRAYOLA SUNGLOW YELLOW ROLL ON HAND SANITIZER - BENZALKONIUM CHLORIDE GEL HEALTH-TECH, INC. _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 FACTS ACTIVE INGREDIENTS Active Ingredients: Benzalkonium Chloride - 0.13% PURPOS E Antimicrobial US ES For hand sanitizing to decrease bacteria on skin For external use only. Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control center right away. Do not use in the eyes. Discontinue use if irritation or redness develops. If condition persists, consult a doctor. DIRECTIONS Remove cap. roll over palms and fingers to wet hands thoroughly. Allow to dry without wiping. Aloe, Vera, Cetrimonium Chloride, Citrus Fragrance, Disodium EDTA, D and C red 33, FD and C yellow 5, Luvigel, Water CRAYOLA SUN GLOW YELLOW ROLL ON LABEL MM20 CRAYOLA BLISTER CARD MM21 CRAYOLA ROLL ON SHIPPER LABEL MM17 CRAYOLA SUNGLOW YELLOW ROLL ON HAND SANITIZER benzalkonium chloride gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:48 8 71-0 0 9 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZA LKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (benzalko nium - UNII:7N6 JUD5X6 Y) Benzalko nium Chlo ride .0 0 13 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALO E VERA LEA F (UNII: ZY8 1Z8 3H0 X) CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP) EDETA TE DISO DIUM (UNII: 7FLD9 1C8 6 K) WA TER (UNII: 0 59 QF0 KO0 R) Health-Tech, Inc. PRODUCT CHARACTERISTICS COLOR yello w (FD and C Yello w 5) S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:48 8 71-0 0 9 -0 1 4 in 1 CASE 1 6 in 1 CARTON 1 1 in 1 BLISTER PACK 1 20 mL in 1 BOTTLE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRA Baca dokumen lengkap