Label: AIRE-MASTER ANTIBACTERIAL LIQUID HANDSOAP- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 65133-180-01, 65133-180-02, 65133-180-03, 65133-180-04, view more65133-180-05, 65133-180-06, 65133-180-07, 65133-180-08, 65133-180-09, 65133-180-10, 65133-180-11, 65133-180-12, 65133-180-14, 65133-180-15, 65133-180-16, 65133-180-17, 65133-180-18, 65133-180-19, 65133-180-20, 65133-180-21, 65133-180-22, 65133-180-23, 65133-180-24, 65133-180-25, 65133-180-26, 65133-180-27, 65133-180-28 - Packager: Aire-Master of America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 29, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Indications
- Directions
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Warnings
Warnings:
-FOR EXTERNAL USE ONLY
-Keep away from eyes. In case of eye contact, flush thoroughly with water
and then seek medical advice.
-If swallowed, drink large amounts of water and seek medical attention.
-Avoid contact with face and broken skin. If contact occurs, flush with
water.
-If irritation develops, discontinue use. If condition persists, consult a
doctor.
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- Other Ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AIRE-MASTER ANTIBACTERIAL LIQUID HANDSOAP
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65133-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.3 g in 10 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO DIETHANOLAMIDE (UNII: 92005F972D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65133-180-14 4 in 1 CASE 01/01/2016 1 NDC:65133-180-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:65133-180-28 708 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2016 3 NDC:65133-180-15 24 in 1 CASE 01/01/2016 3 NDC:65133-180-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:65133-180-03 208198 mL in 1 DRUM; Type 0: Not a Combination Product 01/01/2016 5 NDC:65133-180-16 24 in 1 CASE 01/01/2016 5 NDC:65133-180-04 251 mL in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:65133-180-17 6 in 1 CASE 01/01/2016 6 NDC:65133-180-04 251 mL in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:65133-180-18 24 in 1 CASE 01/01/2016 7 NDC:65133-180-05 251 mL in 1 CONTAINER; Type 0: Not a Combination Product 8 NDC:65133-180-19 8 in 1 CASE 01/01/2016 8 NDC:65133-180-06 1000 mL in 1 POUCH; Type 0: Not a Combination Product 9 NDC:65133-180-20 24 in 1 CASE 01/01/2016 9 NDC:65133-180-07 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:65133-180-21 180 in 1 CASE 01/01/2016 10 NDC:65133-180-07 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:65133-180-22 4 in 1 CASE 01/01/2016 11 NDC:65133-180-08 1893 mL in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:65133-180-23 48 in 1 CASE 01/01/2016 12 NDC:65133-180-09 81 mL in 1 BOTTLE; Type 0: Not a Combination Product 13 NDC:65133-180-10 946353 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2016 14 NDC:65133-180-24 12 in 1 CASE 01/01/2016 14 NDC:65133-180-11 63974 mL in 1 BOTTLE; Type 0: Not a Combination Product 15 NDC:65133-180-25 12 in 1 CASE 01/01/2016 15 NDC:65133-180-11 63974 mL in 1 BOTTLE; Type 0: Not a Combination Product 16 NDC:65133-180-26 6 in 1 CASE 01/01/2016 16 NDC:65133-180-11 63974 mL in 1 BOTTLE; Type 0: Not a Combination Product 17 NDC:65133-180-27 100 in 1 CASE 01/01/2016 17 NDC:65133-180-12 37 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2016 Labeler - Aire-Master of America, Inc. (057897381) Establishment Name Address ID/FEI Business Operations Aire-Master of America, Inc. 057897381 manufacture(65133-180)