ROADPRO Sanitizing wipes by XIAMEN WALLY BATH MANUFACTURE CO., LTD / DAS Companies, Inc.

ROADPRO Sanitizing wipes by

Drug Labeling and Warnings

ROADPRO Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by XIAMEN WALLY BATH MANUFACTURE CO., LTD, DAS Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROADPRO SANITIZING WIPES- alcohol cloth 
XIAMEN WALLY BATH MANUFACTURE 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)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• 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

glycerin, purified water USP

Package Label - Principal Display Panel

100ct NDC: 78868-001-01

20ct NDC: 78868-001-02

10ct NDC: 78868-001-03

ROADPRO SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78868-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1 g  in 100 g
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78868-001-02	76 g in 1 BAG; Type 0: Not a Combination Product	06/15/2020	04/29/2022
2	NDC: 78868-001-03	38 g in 1 BAG; Type 0: Not a Combination Product	06/15/2020	04/29/2022
3	NDC: 78868-001-01	216 g in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020	04/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020	04/29/2022

Labeler - XIAMEN WALLY BATH MANUFACTURE CO., LTD (548232606)

Establishment
Name	Address	ID/FEI	Business Operations
XIAMEN WALLY BATH MANUFACTURE CO., LTD		548232606	manufacture(78868-001)

Revised: 1/2023

Document Id: f2086eca-29f0-8c46-e053-2995a90a1f78

34390-5

Set id: a844d3fe-e039-b5fb-e053-2a95a90ab0a5

Version: 5

Effective Time: 20230111