SurelyWell Alcohol Wipes by Polarized LLC SurelyWell Alcohol Wipes

SurelyWell Alcohol Wipes by

Drug Labeling and Warnings

SurelyWell Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Polarized LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SURELYWELL ALCOHOL WIPES- alcohol cloth 
Polarized 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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SurelyWell Alcohol Wipes

DRUG FACTS

ACTIVE INGREDIENTS:

Ethanol alcohol 75%

PURPOSE:

Antiseptic

USES:

Single use wipes for hands to clean and remove allergens.

WARNINGS:

For external use only. Do not replace wipes used for medical procedures. These wipes are mean for general cleansing. Flammable. Keep away from fire or flame. If eye contact occurs, flush eyes with water. Store at room temperature (59F-86F).

STOP USE:

If irritation and redness develop. If condition continues, consult your health care practitioner.

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a poison control center right away.

Directions:

Unfold towelette, wipe hands, discard after use.

INACTIVE INGREDIENTS:

Water.

Package Labeling:

SURELYWELL ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90094-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90094-075-01	50 in 1 PACKAGE	06/01/2020	08/10/2021
1		3.33 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020	08/10/2021

Labeler - Polarized LLC (117469094)

Revised: 8/2021

Document Id: ca636551-036a-2641-e053-2995a90a4c06

34390-5

Set id: f55d5070-e90a-4f7d-8eee-153d37dee600

Version: 4

Effective Time: 20210825