Antibacterial Wipes Lemon Scent: Package Insert and Label Information

ANTIBACTERIAL WIPES LEMON SCENT- benzalkonium chloride swab
Hangzhou Yitong Biotech 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 0.3%

Purpose

Antiseptic

USE

  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to hlep prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.

Warning

  • For external use only.
  • Do not use in or contact the eyes
  • Stop use and ask a doctor, if too much skin irritaion and sensitivity develops or increases.

If swallowed, get medical help or contact a Poison Contrl Center immediately.

Directions

  • Gently pull back resealable label, remove and use wipe as required.
  • Reseal back after use.

Inactive ingredients

Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben, Methylparaben, Polysorbate 20, Fragrance, Disodium EDTA, Sodium Citrate, Cetylpyridinium Chloride.

label image
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ANTIBACTERIAL WIPES LEMON SCENT
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77907-014
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
water
DMDM HYDANTOIN
ETHYLPARABEN
PHENOXYETHANOL
METHYLPARABEN
POLYSORBATE 20
SODIUM CITRATE
CETYLPYRIDINIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77907-014-01 10 POUCH in 1 BAG contains a POUCH
1 50 g in 1 POUCH This package is contained within the BAG (77907-014-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/29/2020
Labeler — Hangzhou Yitong Biotech Co., Ltd. (554532766)
Establishment
Name Address ID/FEI Operations
Hangzhou Yitong Biotech Co., Ltd. 554532766 manufacture (77907-014)

Revised: 06/2020 Hangzhou Yitong Biotech Co., Ltd.

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