Bye Bye Germs Antibacterial Wipes: Package Insert and Label Information

BYE BYE GERMS ANTIBACTERIAL WIPES- benzalkonium chloride cloth
Kangna (Zhejiang) Medical Supplies Co., Ltd.

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.

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

Antiseptic cleanser, helps decrease bacteria on skin.

Warnings

For external use only.

When using this product

Avoid contact with the eyes; in case of contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops and persists

Keep out of reach of children.

If injested, get medical help or contact a Poison Control Center right away

Directions

  • Lift tab and pull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
  • Reseal after use to prevent moisture from evaporating.
  • Children under 6 years of age should be supervised when using this product.

Other information

Store at room temperature.

Inactive ingredients

Water (Aqua), Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

Questions?

Call 1-800-548-4097

Label copy

image of the label
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BYE BYE GERMS ANTIBACTERIAL WIPES
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75109-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13
Inactive Ingredients
Ingredient Name Strength
WATER
POLYSORBATE 20
EDETATE DISODIUM ANHYDROUS
PHENOXYETHANOL
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75109-002-01 75 CLOTH in 1 POUCH None
2 NDC:75109-002-02 75 CLOTH in 1 CANISTER None
3 NDC:75109-002-03 25 CLOTH in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/05/2020
Labeler — Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
Establishment
Name Address ID/FEI Operations
Kangna (Zhejiang) Medical Supply Co., Ltd. 554530173 manufacture (75109-002)

Revised: 10/2020 Kangna (Zhejiang) Medical Supplies Co., Ltd.

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