EXTRA STRENGTH SANITIZING WIPES- extra strength sanitizing wipes patch
Shandong Tricol Marine Biological Technology Co.,Ltd

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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Active Ingredient(s)

Alcohol 75% w/w. Purpose: Antiseptic

Purpose

Antiseptic

Use

to help reduce bacteria on the skin. 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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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. If swallowed, get medical help or contact a Poison Control Center right away.

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Open packet,remove and unfold pre-moistened tissue.
Thoroughly clean hands or affected area and discard in receptacle.Do not flush.
Allow to dry without wiping
Be sure to reseal packet completely to retain moisture

Other information

Store at room temperature

Inactive ingredients

water

Package Label - Principal Display Panel

package label

EXTRA STRENGTH SANITIZING WIPES
extra strength sanitizing wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54156-003
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54156-003-01	1 in 1 PACKET	11/20/2020
1		4 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:54156-003-02	24 in 1 PACKET	11/20/2020
2		4 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC:54156-003-03	10 in 1 PACKET	11/20/2020
3		4 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC:54156-003-04	20 in 1 PACKET	11/20/2020
4		4 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC:54156-003-05	48 in 1 PACKET	11/20/2020
5		4 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC:54156-003-06	96 in 1 PACKET	11/20/2020
6		4 g in 1 PATCH; Type 0: Not a Combination Product
7	NDC:54156-003-07	35 in 1 CANISTER	11/20/2020
7		4 g in 1 PATCH; Type 0: Not a Combination Product
8	NDC:54156-003-08	70 in 1 CANISTER	11/20/2020
8		4 g in 1 PATCH; Type 0: Not a Combination Product
9	NDC:54156-003-09	96 in 1 CANISTER	11/20/2020
9		4 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	03/30/2020

Labeler - Shandong Tricol Marine Biological Technology Co.,Ltd (541569370)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Tricol Marine Biological Technology Co.,Ltd		541569370	manufacture(54156-003)