Alcohol Wipes — v1

Alcohol Wipes

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Version

v1

Effective date

September 30, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
e82495cc-1573-486d-b4cb-d4a7d57ab912
Set ID
433e58c6-470a-4d6c-9e90-a2eef742e128
Application numbers
505G(a)(3)
Product NDCs
77412-199
Package NDCs
77412-199-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Alcohol Wipes
Generic names
ETHYL ALCOHOL
Manufacturer names
Shandong Liaocheng Chaoyue Daily Necessities Co., Ltd.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ALCOHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
3K9958V90M
UPC
0810051640793

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient Ethyl Alcohol 75% v/v
Dosage And Administration (1)

Sequence 1

Directions: Single use wipes for hands. Close properly after dispensing to maintain purity,as alcohol by its nature evaporates quickly. Dispose of properly. DO NOT FLUSH. Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients: Glycerol, Water.
Indications And Usage (1)

Sequence 1

use To help reduce bacteria that potentially can cause disease
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out ofreach of children If swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel (1)

Sequence 1

image description
Purpose (1)

Sequence 1

Purpose Antiseptic
Spl Product Data Elements (1)

Sequence 1

Alcohol Wipes Ethyl Alcohol ALCOHOL ALCOHOL water
Stop Use (1)

Sequence 1

Stop use and ask a doctor if lrritation and redness develop. Condition persists for more than 72 hours.
Storage And Handling (1)

Sequence 1

Other Information Keep out of light; store at room temperature 59°F-86°F
Warnings (1)

Sequence 1

Warnings For external use only; hands, general cleansing. Does not replace wipes used for medical procedures. Flammable； keep away from fire or flame. Do not ingest.
When Using (1)

Sequence 1

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Alcohol Wipes'],
 'generic_name': ['ETHYL ALCOHOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Shandong Liaocheng Chaoyue Daily Necessities Co., '
                       'Ltd.'],
 'package_ndc': ['77412-199-01'],
 'product_ndc': ['77412-199'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['e82495cc-1573-486d-b4cb-d4a7d57ab912'],
 'spl_set_id': ['433e58c6-470a-4d6c-9e90-a2eef742e128'],
 'substance_name': ['ALCOHOL'],
 'unii': ['3K9958V90M'],
 'upc': ['0810051640793']}