STERILIZED WET WIPES patch

Sterilized wet wipes by

Drug Labeling and Warnings

Sterilized wet wipes by is a Otc medication manufactured, distributed, or labeled by Shandong Aishule Hygiene Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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. Flammable. Keep away from heat or flame.

DO NOT USE

in children less than 2 months of age.

on open skin wounds.

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces.

STORAGE AND HANDLING

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

INACTIVE INGREDIENT

CELLULOSE, WATER, CETYLPYRIDINIUM CHLORIDE, BENZETHONIUM CHLORIDE, PROPYLENE GLYCOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERILIZED WET WIPES 
sterilized wet wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82061-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.0018 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.0015 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.9967 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82061-007-02	80 in 1 PATCH	03/26/2023
1	NDC: 82061-007-01	3.3 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	03/26/2023

Labeler - Shandong Aishule Hygiene Products Co., Ltd (541645991)

Registrant - Shandong Aishule Hygiene Products Co., Ltd (541645991)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Aishule Hygiene Products Co., Ltd		541645991	manufacture(82061-007)