SIMPLY SAFER DISINFECTANT WIPE- alcohol cloth
Simply Safer Products 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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DISINFECTANT WIPES

Active Ingredient(s)

Alcohol 75% Purpose: Antiseptic

Purpose

Antiseptic, wipes

Uses

For handwashing to decrease bacteria on the skin.

Directions

Open label, remove wipe, and unfold
Wet hands thoroughly with product and allow to dry without wiping

Warnings

For external use only. Do not use in the eyes. Do not flush.

Discontinue use if irritation and redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store below 95F (35C)
May discolor certain fabrics or surfaces

Inactive ingredients

BENZALKONIUM CHLORIDE, WATER, CETYLPYRIDINIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE, PHENOXYETHANOL, GLYCERIN, N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)

Package Label - Principal Display Panel

1PC NDC: 79754-002-01

PDP

SIMPLY SAFER DISINFECTANT WIPE
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79754-002(NDC:40562-011)
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 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79754-002-01	1 in 1 BAG	07/23/2020
1		6 g in 1 PATCH; 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	07/23/2020

Labeler - Simply Safer Products Llc (117579462)