SANITIZER WIPES 70% ETHYL ALCOHOL- alcohol cloth 
Empack Spraytech Inc.

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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This is a hand sanitizer wipes with Alcohol 70% v/v.

Active Ingredient

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic

Uses

• 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.

Flammability warning Keep away from open flame and sources of heat.

Do not use • on children less than 2 months of age • on open skin wounds.

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation develops.

Keep out of reach of children. Topical. If swallowed, call a poison control centre or get medical help right away.

Directions

• Adults and children over 2 years: • For occasional and personal domestic use • Supervise children under 6 years of age when using this product to avoid swallowing • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

• Store at room temperature 15-30°C (59-86°F)
• Avoid freezing and extensive heat above 40°C (104°F)

Inactive ingredients

Water, Fragrance

Package Label - Principal Display Panel

LabelLabel

SANITIZER WIPES 70% ETHYL ALCOHOL 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-017
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
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-017-01100 in 1 CANISTER09/14/2021
15 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:50021-017-02180 in 1 CANISTER09/14/2021
25 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/14/2021
Labeler - Empack Spraytech Inc. (252047519)
Registrant - Empack Spraytech Inc. (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc.252047519manufacture(50021-017)

Revised: 9/2021
Document Id: cbe404fb-8553-eee4-e053-2995a90a068d
Set id: cbe404fb-8561-eee4-e053-2995a90a068d
Version: 1
Effective Time: 20210914
 
Empack Spraytech Inc.