Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
SAO THAI DUONG JOINT STOCK COMPANY - BRANCH
TOPICAL
OTC DRUG
For hand washing to decrease bacteria on the skin
OTC monograph not final
THAI DUONG HAND SANITIZER ANTISEPTIC HAND RUB- ALCOHOL GEL SAO THAI DUONG JOINT STOCK COMPANY - BRANCH ---------- THAI DUONG HAND SANITIZER ANTISEPTIC HAND RUB _DRUG FACTS_ _ACTIVE INGREDIENT_ Ethyl alcohol 70% _PURPOSE_ Antiseptic _USES_ For hand washing to decrease bacteria on the skin _WARNINGS_ For external use only. Flammable, keep away from fire or flame DO NOT USE in the eyes STOP USE AND ASK A DOCTOR IF: irritation and redness develop condition persists for more than 72 hours KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Wet hands thoroughly with product and allow to dry without wiping. _OTHER INFORMATION_ Store below 59°F-86°F (15°C-30°C). Avoid freezing and excessive heat above 104°F (40°C). _INACTIVE INGREDIENTS_ Argan Oil, Carbomer, Peppermint Oil, Propylene Glycol, Sodium Hydroxide, Water. PACKAGE LABELING: THAI DUONG HAND SANITIZER ANTISEPTIC HAND RUB alcohol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:81379-001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ARGAN OIL (UNII: 4V59G5UW9X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PEPPERMINT OIL (UNII: AV092KU4JH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) PACKAGING MARKETING START MARKETING END SAO THAI DUONG JOINT STOCK COMPANY - BRANCH # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:81379-001- 00 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 04/27/2021 LABELER - SAO THAI DUONG JOINT STOCK COMPANY - BRANCH (556392842) Revised: 11/2023 Read the complete document