ANTIBACTERIAL ALCOHOL WIPES- alcohol cloth

Antibacterial Alcohol Wipes by

Drug Labeling and Warnings

Antibacterial Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Urigel, Urigel Inc, Antisépticos de México, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

EthylAlcohol 80%. Purpose: Antibacterial

Purpose

Antibacterial, Hand Sanitizer

Use

For handwashing to decrease bacteria on skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• on children less than 2 months of age
• on open skin wounds
• over large areas of the body or if you are allergic to any of these ingredients.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, 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.

Directions

• To use, pull out wipe and reseal container to maintain moisture.
• Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle.
• Do not flush.
• Rub hands together briskly to dry.

Other information

• Store between 59-86 °F (15-30 °C)
• Avoid freezing and excessive heat
• Dispose of contents/container responsibly
  

Inactive ingredients

Water, Glycerin.

Principal Display Panel 450 units

80 each Sanitizer Wipes

80 Each NDC: 80924-110-01

100 Each Sanitizer Wipes

100 Each NDC: 80924-110-02

450 Sanitizer Wipes

450 Each NDC: 80924-110-03

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80924-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80924-110-03	450 g in 1 CANISTER; Type 0: Not a Combination Product	10/30/2020
2	NDC: 80924-110-01	80 g in 1 CANISTER; Type 0: Not a Combination Product	10/01/2020
3	NDC: 80924-110-02	100 g in 1 CANISTER; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2020

Labeler - Urigel (117688244)

Registrant - Urigel Inc (117688244)

Establishment
Name	Address	ID/FEI	Business Operations
Antisépticos de México, S.A. de C.V.		951576637	manufacture(80924-110)