75 ALCOHOL WIPES- alcohol cloth
Newacme 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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75% Alcohol Wipes

Drug Facts

Active Ingredient

Ethyl alcohol 75%

Purpose

Antibacterial

Uses

To decrease bacteria on the skin that could cause disease. Recommended to use repeatedly.

Warnings

For external use only.

please put in a cool and dry place avoid direct sunlight and very warm temperature.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

Wet skin thoroughly with this products and allow to dry. Discard wipes in a recyclable trash can after use.

Inactive Ingredients

Butane-1,3-diol, Glycerol, Pure water, Aloe extract

Package Labeling:

Label

75 ALCOHOL WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74341-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74341-018-01	20 in 1 BAG	07/10/2020
1		4.25 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/10/2020

Labeler - Newacme LLC (117465743)

Name	Address	ID/FEI	Business Operations
Establishment
Baijieyuan Biotechnology (Shandong) Co., Ltd.		554531114	manufacture(74341-018)