Sanitizing Hand Wipe Mitts: Package Insert and Label Information

SANITIZING HAND WIPE MITTS — alcohol cloth
Foshan Clean & Simple Cleaning Products 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.

Sanitizing Hand Wipe Mitts

Active Ingredient(s)

Alcohol 12ml/pcs. Purpose: Antiseptic

Purpose

Antiseptic, Sanitizing Hand Wipe Mitts

Use

Sanitizing Hand Wipe Mitts to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

  • Wipe the surface of the skin and let it dry naturally

Other information

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

Inactive ingredients

purified water USP

Package Label — Principal Display Panel

label
(click image for full-size original)

SANITIZING HAND WIPE MITTS
alcohol cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77980-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 24 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77980-112-01 2 CLOTH in 1 BAG None
2 NDC:77980-112-02 3 CLOTH in 1 BAG None
3 NDC:77980-112-03 5 CLOTH in 1 BAG None
4 NDC:77980-112-04 8 CLOTH in 1 BAG None
5 NDC:77980-112-05 10 CLOTH in 1 BAG None
6 NDC:77980-112-06 15 CLOTH in 1 BAG None
7 NDC:77980-112-07 20 CLOTH in 1 BAG None
8 NDC:77980-112-08 25 CLOTH in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/30/2021
Labeler — Foshan Clean & Simple Cleaning Products Co., Ltd. (407577237)
Establishment
Name Address ID/FEI Operations
Foshan Clean & Simple Cleaning Products Co., Ltd. 407577237 manufacture (77980-112)

Revised: 06/2021 Foshan Clean & Simple Cleaning Products Co., Ltd.

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