SANITIZER WIPES 70% ETHYL ALCOHOL- alcohol cloth

Sanitizer Wipes 70% Ethyl Alcohol by

Drug Labeling and Warnings

Sanitizer Wipes 70% Ethyl Alcohol by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

WHEN USING

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

STOP USE

Stop use and ask a doctor if irritation develops.

KEEP OUT OF REACH OF CHILDREN

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

Label

INGREDIENTS AND APPEARANCE

SANITIZER WIPES 70% ETHYL ALCOHOL 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

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: 50021-017-01	100 in 1 CANISTER	09/14/2021
1		5 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50021-017-02	180 in 1 CANISTER	09/14/2021
2		5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/14/2021

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc.		252047519	manufacture(50021-017)