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- Contains inactivated NDC Code(s)
NDC Code(s): 80903-013-20 - Packager: G&Y PRODUCTS 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 February 1, 2022
If you are a consumer or patient please visit this version.
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- Active Ingredient(s)
Benzalkonium Chloride 0.13% w/w
- Purpose
- Uses
For handwashing to decrease bacteria on the skin.
- Warnings
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.
- Cloth
- Directions
- Storage: Store at room temperature
- Dispensing: Peel back label slowly. Pull out wipe and reseal label. Close label to retain moisture.
- Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
- Disposal: Dispose of used wipes in trash receptable after use. Do not flush.
- Inactive Ingredients
Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate.
- Package label
Kills 99.9% of Germs that 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 PM
Distributed 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 WET WIPES
g and y antibacterial wet wipes clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80903-013 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 in3.5mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PHENOXYETHANOL (UNII: HIE492ZZ3T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) C12-15 PARETH-12 (UNII: 131316X18L) GLYCERIN (UNII: PDC6A3C0OX) BENZOIC ACID (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80903-013-20 20 in 1 PACKAGE 07/03/2020 1 3.5 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 07/03/2020 Labeler -G&Y PRODUCTS INC.(081236664)
Registrant -G AND Y PRODUCTS INC. (081236664)
Establishment Name Address ID/FEI Business Operations ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 565415460 manufacture(80903-013)
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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 WET WIPES cloth
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Feb 2, 2022 | 3 (current) | download |
| Jan 4, 2021 | 1 | download |
RxNorm
G AND Y ANTIBACTERIAL WET WIPES cloth
Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.
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G AND Y ANTIBACTERIAL WET WIPES cloth
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NDC Codes
G AND Y ANTIBACTERIAL WET WIPES cloth
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 80903-013-20 (inactivated) |
