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- Contains inactivated NDC Code(s)
NDC Code(s): 77613-010-20, 77613-010-90 - Packager: ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
- 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 May 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- Drug Facts
- Active ingredients
Benzalkonium Chloride 0.13% w/w
- Purpose
Antibacterial
- Uses
For handwashing to decrease bacteria on the skin
- Warning
For external use only
Do not use
▪in the eyes.
▪if you are allergic to any of the ingredients.When using this product if eye contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation and redness develop and persist 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
•Storage. Store at room temperature.
• Dispensing. Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture.
•Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
•Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.
- Other information
Production Date, Expiry Date and Lot Number on side
- Inactive ingredients
Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water,Tetrasodium Glutamate Diacetate.
- SPL UNCLASSIFIED SECTION
Kills 99.9% of Germsthat may cause illness.
6.3 IN x 7.1 IN
(16 cm x 18 cm)Questions? +1 (862) 257-3339
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PMDistributed by: G&Y Products, Inc.
25 Shady St, Paterson, NJ 07524
info@gyproduct.com
Country of origin : Turkey
- Packaging
- INGREDIENTS AND APPEARANCE
G AND Y ANTIBACTERIAL HAND WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77613-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13g in100mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) C12-15 PARETH-12 (UNII: 131316X18L) DEHYDROACETIC ACID (UNII: 2KAG279R6R) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77613-010-20 20 in 1 PACKAGE 05/14/2020 1 3.5 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:77613-010-90 90 in 1 PACKAGE 05/14/2020 2 3.5 mL in 1 PACKET; 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 05/14/2020 Labeler -ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI(565415460)
Establishment Name Address ID/FEI Business Operations ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 565415460 manufacture(77613-010)
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Safety
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Related Resources
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More Info on this Drug
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G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| May 26, 2020 | 1 (current) | download |
RxNorm
G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1038558 | benzalkonium chloride 0.13 % Medicated Pad | PSN |
| 2 | 1038558 | benzalkonium chloride 1.3 MG/ML Medicated Pad | SCD |
| 3 | 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Patch | SY |
| 4 | 1038558 | benzalkonium chloride 0.13 GM per 100 GM Topical Swab | SY |
| 5 | 1038558 | benzalkonium chloride 0.13 % Topical Swab | SY |
| 6 | 1038558 | benzalkonium chloride 1 ML per 750 ML Topical Swab | SY |
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G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
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NDC Codes
G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 77613-010-20 (inactivated) |
| 2 | 77613-010-90 (inactivated) |
