Yangzhou Zhouwan Medical Devices Co.,ltd

SPL v1

SPL

SPL Set ID b3b9787e-19eb-2ca3-e053-2a95a90a5334

Route

TOPICAL

Published

Effective Date 2020-11-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-11-10

Description

Ethyl Alcohol 70%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70%

Use

To help reduce microbes on the skin.

Section 50565-1

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9

Stop using and ask a doctor if: irritation or redness develops and lasts.

Section 50567-7

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Warnings

For external use only.
Do not dispose of wipes in flush toilets.
Flammable: Keep away from fire or flame.

Directions

Apply to hands or skin.
No rinsing required.
Discard after use.

Other Information

Store below 110 °F（43° C).
May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients

Water(Aqua).

Package Label Principal Display Panel

75pcs NDC: 96285-002-01

20pcs NDC: 96285-002-02

Structured Label Content

Use

To help reduce microbes on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor if: irritation or redness develops and lasts.

Section 50567-7 (50567-7)

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Purpose

Antimicrobial

Warnings

For external use only.
Do not dispose of wipes in flush toilets.
Flammable: Keep away from fire or flame.

Directions

Apply to hands or skin.
No rinsing required.
Discard after use.

Other Information (Other information)

Store below 110 °F（43° C).
May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)

Water(Aqua).

Package Label Principal Display Panel (Package Label - Principal Display Panel)

75pcs NDC: 96285-002-01

20pcs NDC: 96285-002-02

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To help reduce microbes on the skin.", "50565-1": "Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.", "50566-9": "Stop using and ask a doctor if: irritation or redness develops and lasts.", "50567-7": "When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "For external use only. Do not dispose of wipes in flush toilets. Flammable: Keep away from fire or flame.", "Directions": "Apply to hands or skin. No rinsing required. Discard after use.", "Other information": "Store below 110 °F（43° C). May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Ethyl Alcohol 70%", "Inactive ingredients": "Water(Aqua).", "Package Label - Principal Display Panel": "75pcs NDC: 96285-002-01 20pcs NDC: 96285-002-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:01.308713 · Updated: 2026-03-14T22:58:50.271611