OTC Medication Information: Unihope Sterilization Wipes

UNIHOPE STERILIZATION WIPES- benzalkonium chloride and alcohol cloth
Quanzhou Zhuotai 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(s)

Alcohol 75%,Benzalkonium chloride(0.0859%-0.095%). Purpose: Antiseptic

Purpose

Spunlace non-woven:Pure cotton texture, soft and thick.Natural:with centella asiatica extract.Our product is pure ,mild,alcohol free,and mit/cit free.Scope of application;it is applicable to wipe hand ,face ,skin ,etc. and avoid to use on sensitice areas,such as eyes and wounds.
Instructions:Just open the lid and use it. Action time for hand ≤ 1min, action time for intact skin ≤ 5min.

Use

Spunlace non-woven:Pure cotton texture, soft and thick.Natural:with centella asiatica extract.Our product is pure ,mild,alcohol free,and mit/cit free.Scope of application;it is applicable to wipe hand ,face ,skin ,etc. and avoid to use on sensitice areas,such as eyes and wounds.
Instructions:Just open the lid and use it. Action time for hand ≤ 1min, action time for intact skin ≤ 5min.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Spunlace non-woven:Pure cotton texture, soft and thick.Natural:with centella asiatica extract.Our product is pure ,mild,alcohol free,and mit/cit free.Scope of application;it is applicable to wipe hand ,face ,skin ,etc. and avoid to use on sensitice areas,such as eyes and wounds.
    Instructions:Just open the lid and use it. Action time for hand ≤ 1min, action time for intact skin ≤ 5min.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water

Package Label — Principal Display Panel

60 COLOTH LAbel
(click image for full-size original)

UNIHOPE STERILIZATION WIPES
alcohol,benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41636-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 85.9 mg in 100
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100
Inactive Ingredients
Ingredient Name Strength
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code unihope
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41636-100-60 60 CLOTH in 1 BAG None
2 NDC:41636-100-50 50 CLOTH in 1 BAG None
3 NDC:41636-100-80 80 CLOTH in 1 BAG None
4 NDC:41636-100-40 40 CLOTH in 1 BAG None
5 NDC:41636-100-20 20 CLOTH in 1 BAG None
6 NDC:41636-100-10 10 CLOTH in 1 BAG None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/01/2020
Labeler — Quanzhou Zhuotai Supplies Co., Ltd. (416368085)
Registrant — Quanzhou Zhuotai Supplies Co., Ltd. (416368085)
Establishment
Name Address ID/FEI Operations
Quanzhou Zhuotai Supplies Co., Ltd. 416368085 manufacture (41636-100)

Revised: 07/2020 Quanzhou Zhuotai Supplies Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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