ROADPRO Hand Sanitizer by Xiamen Wally Bath Manufacture Co., Ltd

ROADPRO Hand Sanitizer by

Drug Labeling and Warnings

ROADPRO Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Xiamen Wally Bath Manufacture Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROADPRO HAND SANITIZER- alcohol liquid 
Xiamen Wally Bath Manufacture Co., Ltd

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Active Ingredient(s)

Alcohol 70% 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, PEG-40 Hydrogenated Castor Oil,Carbomer, purified water USP, etc

Package Label - Principal Display Panel

59 mL NDC: 78868-002-01

hand sanitizer 59 ml label

30 mL NDC: 78868-002-02

hand sanitizer 30 ml label

760mL NDC: 78868-002-03

hand sanitizer 760 ml label

1740mL NDC: 78868-002-04

hand sanitizer 1.74L label

ROADPRO HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78868-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78868-002-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC: 78868-002-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC: 78868-002-041740 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC: 78868-002-03760 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00303/30/202012/01/2023
Labeler - Xiamen Wally Bath Manufacture Co., Ltd (548232606)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Wally Bath Manufacture Co., Ltd548232606manufacture(78868-002)

Revised: 7/2024
Document Id: 1cb82f79-8485-d69a-e063-6294a90abe83
Set id: a87fa7de-a2ad-1981-e053-2995a90a2b5b
Version: 4
Effective Time: 20240708