Zhejiang Meimi Technology Co., Ltd.

SPL v2

SPL

SPL Set ID dcebf021-9d6b-bfae-e053-2a95a90a0510

Route

EXTRACORPOREAL

Published

Effective Date 2021-04-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Yellow No. 6 Fd&c Red No. 4 Trolamine Water Propylene Glycol Glycerin Carbomer 940 Coffee Bean

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-18

Description

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v

Use

Uses hand sanitizer to help reduce bacteria on skin.

Section 50565-1

Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation, excessive redness or rash develops.

Warnings

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

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Do Not Use

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

Other Information

Store below 110℉(43℃).

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, yellow 6, red 4, blue 1.

Package Label Principal Display Panel

59 mL in 1 BOTTLE NDC: 41366-051-01

59 mL in 1 BOTTLE NDC: 41366-051-02

Structured Label Content

Use

Uses hand sanitizer to help reduce bacteria on skin.

Section 50565-1 (50565-1)

Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation, excessive redness or rash develops.

Purpose

Antimicrobial

Warnings

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

Directions

Put a dime sized drop onto hands and rub together briskly until dry.

Do Not Use (Do not use)

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

Other Information (Other information)

Store below 110℉(43℃).

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, yellow 6, red 4, blue 1.

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

59 mL in 1 BOTTLE NDC: 41366-051-01

59 mL in 1 BOTTLE NDC: 41366-051-02

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COFFEE BEAN", "unii": "JFH385Y744", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Uses hand sanitizer to help reduce bacteria on skin.", "50565-1": "Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation, excessive redness or rash develops.", "Purpose": "Antimicrobial", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Put a dime sized drop onto hands and rub together briskly until dry.", "Do not use": "Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.", "Other information": "Store below 110℉(43℃).", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v", "Inactive ingredients": "Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, yellow 6, red 4, blue 1.", "Package Label - Principal Display Panel": "59 mL in 1 BOTTLE NDC: 41366-051-01 59 mL in 1 BOTTLE NDC: 41366-051-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.502055 · Updated: 2026-03-14T23:02:25.522673