Extra Strength Sanitizing Wipes: Package Insert and Label Information

EXTRA STRENGTH SANITIZING WIPES- alcohol 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.

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54156-003-01 1 PATCH in 1 PACKET contains a PATCH
1 4 g in 1 PATCH This package is contained within the PACKET (54156-003-01)
2 NDC:54156-003-02 24 PATCH in 1 PACKET contains a PATCH
2 4 g in 1 PATCH This package is contained within the PACKET (54156-003-02)
3 NDC:54156-003-03 10 PATCH in 1 PACKET contains a PATCH
3 4 g in 1 PATCH This package is contained within the PACKET (54156-003-03)
4 NDC:54156-003-04 20 PATCH in 1 PACKET contains a PATCH
4 4 g in 1 PATCH This package is contained within the PACKET (54156-003-04)
5 NDC:54156-003-05 48 PATCH in 1 PACKET contains a PATCH
5 4 g in 1 PATCH This package is contained within the PACKET (54156-003-05)
6 NDC:54156-003-06 96 PATCH in 1 PACKET contains a PATCH
6 4 g in 1 PATCH This package is contained within the PACKET (54156-003-06)
7 NDC:54156-003-07 35 PATCH in 1 CANISTER contains a PATCH
7 4 g in 1 PATCH This package is contained within the CANISTER (54156-003-07)
8 NDC:54156-003-08 70 PATCH in 1 CANISTER contains a PATCH
8 4 g in 1 PATCH This package is contained within the CANISTER (54156-003-08)
9 NDC:54156-003-09 96 PATCH in 1 CANISTER contains a PATCH
9 4 g in 1 PATCH This package is contained within the CANISTER (54156-003-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — Shandong Tricol Marine Biological Technology Co.,Ltd (541569370)
Establishment
Name Address ID/FEI Operations
Shandong Tricol Marine Biological Technology Co.,Ltd 541569370 manufacture (54156-003)

Revised: 01/2021 Shandong Tricol Marine Biological Technology Co.,Ltd

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