Label: ALLWIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 81297-101-01, 81297-101-02, 81297-101-03 - Packager: JAINAM INVAMED PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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 December 23, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses:
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Warnings
For external use only.
Flammable: Keep away from fire or flame.
Do Not Use
• In Children in less than 2 months of age. • On Open skin Wound.
When using this product avoid contact with eyes and mouth. If in eyes, flush thoroughly with water.
Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours.
- Directions:
- Inactive Ingredients
- Other Information:
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SPL UNCLASSIFIED SECTION
HAND AND BODY SANITIZING WIPES
KILLS 99.99% OF GERMS
EFFECTIVE & QUICK DRYING
Mild, non-irritating and safe for skin. Reduces the fear of infection. Use for hands and surfaces, that are used by multiple people: Mobile cell phones, Handles, Switches, Door bell buttons, Elevator buttons, Public transport, Common Laptops, equipment, Public Waiting areas etc. These wipes can be used to disinfect electronic equipment like handheld gadgets.
Manufactured by:
jainam invamed Private Limited
111,112, Shubh Ind Est,
Nr Chinchpada Bus Stop,
Waliv Rd, Vasai(E)-401208,
Mumbai, Maharashtra, India.
E-mail: sales@allwipes.in
Web: www.allwipes.in
Customer care No.: +91 9819446969
ISO 9001.2015
13485:2016
- Packaging
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INGREDIENTS AND APPEARANCE
ALLWIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81297-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81297-101-01 1 in 1 PACKET 12/21/2020 1 2 mL in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:81297-101-02 25 in 1 CANISTER 12/21/2020 2 3 mL in 1 PACKAGE; Type 0: Not a Combination Product 3 NDC:81297-101-03 60 in 1 CANISTER 12/21/2020 3 3 mL in 1 PACKAGE; 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 part333A 12/21/2020 Labeler - JAINAM INVAMED PRIVATE LIMITED (854117783) Establishment Name Address ID/FEI Business Operations JAINAM INVAMED PRIVATE LIMITED 854117783 manufacture(81297-101)
