TIZER WIPES- alcohol liquid
The PnR Group, LLC

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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Tizer Wipes

Active Ingredient(s)

Alcohol 75% v/v.

Purpose

Disinfect

Use

For cleaning and disinfecting.

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

In case of contact with eyes, flush, thoroughly with water. Use wipes only on unbroken, intact skin. If you have sensitive skin, check the list of ingredients on the label before using wipes. Do not ingest.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. Children under 6 years only under adult supervision.

Directions

Wipe hands thoroughly, let skin dry and discard.
Not recommend for infants.

Other information

Do not store above 105F. May discolor some fabrics.

Inactive ingredients

Purified water, non-woven fabric.

Package Label - Principal Display Panel

label

TIZER WIPES
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80628-101
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80628-101-01	1 in 1 CONTAINER	03/30/2020
1		330 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - The PnR Group, LLC (117490922)

Name	Address	ID/FEI	Business Operations
Establishment
FuYang YangYang Health Technology Co. Pty		529735460	manufacture(80628-101)