SANITIZING ISOPROPYL ALCOHOL WIPES by Hangzhou Wellbeing Technology Co., Ltd.

SANITIZING ISOPROPYL ALCOHOL WIPES by

Drug Labeling and Warnings

SANITIZING ISOPROPYL ALCOHOL WIPES by is a Otc medication manufactured, distributed, or labeled by Hangzhou Wellbeing Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITIZING ISOPROPYL ALCOHOL WIPES- hand sanitizer cloth 
Hangzhou Wellbeing Technology 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.

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Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Isopropyl Alcohol Antiseptic Wipes 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. Not suitable for delicate skin.

Do not use

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

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 with a damp paper towel until it is dry. Do not rinse with water immediately after wiping.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

fragrance, purified water USP.

Package Label - Principal Display Panel

10 WIPES in 1 BAG NDC: 78416-024-01

Package Label - Principal Display Panel

50 WIPES in 1 BAG NDC: 78416-024-02

Package Label - Principal Display Panel

80 WIPES in 1 PAIL NDC: 78416-024-03

SANITIZING ISOPROPYL ALCOHOL WIPES 
hand sanitizer cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78416-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78416-024-01	62 g in 1 BAG; Type 0: Not a Combination Product	11/10/2020
2	NDC: 78416-024-02	280 g in 1 BAG; Type 0: Not a Combination Product	11/10/2020
3	NDC: 78416-024-03	365 g in 1 PAIL; Type 0: Not a Combination Product	11/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/10/2020	12/31/2021

Labeler - Hangzhou Wellbeing Technology Co., Ltd. (414010999)

Registrant - Hangzhou Wellbeing Technology Co., Ltd. (414010999)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Wellbeing Technology Co., Ltd.		414010999	manufacture(78416-024)

Revised: 4/2022

Document Id: dd39adf4-ec70-f62a-e053-2a95a90a89bb

34390-5

Set id: b3a9acb9-132d-108f-e053-2995a90a63fb

Version: 3

Effective Time: 20220422