Shandong Oushile Biotechnology Co.ltd

SPL v32657

SPL

SPL Set ID 9d06f6e4-7442-4c15-9b4a-ccf8ff27b42d

Route

TOPICAL

Published

Effective Date 2020-08-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Cetylpyridinium Chloride Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-08-04

Description

Ethyl Alcohol 75% v/v

Purpose

Ethyl Alcohol Antiseptic

Medication Information

Purpose

Ethyl Alcohol Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

Helps reduce bacteria that potentially can cause disease.

Section 51945-4

Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Warnings

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

Directions

Open the package and wipe skin until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

in children less than 2 months of age.
on open skin wounds.

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

CETYLPYRIDINIUM CHLORIDE, WATER

When Using This Product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep Out of Reach of Children.

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

Package Label Principal Display Panel

Manufactured By Shandong Oushile Biotechnology Co.ltd

Made in China

Distributed by Rixi Group USA, Inc

8966 Mason Ave, Chatsworth, CA 91311

Phone: (818)341-6600

[email protected]

Structured Label Content

Use

Helps reduce bacteria that potentially can cause disease.

Section 51945-4 (51945-4)

Purpose

Ethyl Alcohol Antiseptic

Stop Use (Stop use)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Warnings

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

Directions

Open the package and wipe skin until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

in children less than 2 months of age.
on open skin wounds.

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

CETYLPYRIDINIUM CHLORIDE, WATER

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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.

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

Manufactured By Shandong Oushile Biotechnology Co.ltd (Manufactured by Shandong Oushile Biotechnology Co.Ltd)

Made in China

Distributed by Rixi Group USA, Inc

8966 Mason Ave, Chatsworth, CA 91311

Phone: (818)341-6600

[email protected]

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "1"}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Helps reduce bacteria that potentially can cause disease.", "Purpose": "Ethyl Alcohol Antiseptic", "Stop use": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Open the package and wipe skin until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "in children less than 2 months of age. on open skin wounds.", "Active Ingredient": "Ethyl Alcohol 75% v/v", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Inactive ingredients": "CETYLPYRIDINIUM CHLORIDE, WATER", "When using this product": "keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Manufactured by Shandong Oushile Biotechnology Co.Ltd": "Made in China Distributed by Rixi Group USA, Inc 8966 Mason Ave, Chatsworth, CA 91311 Phone: (818)341-6600 gary@rixiglobal.net"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:23.618754 · Updated: 2026-03-14T22:57:54.086638