ad654143-1c44-51c1-e053-2a95a90a1b7b

SPL v1
SPL
SPL Set ID ad654143-1c44-51c1-e053-2a95a90a1b7b
Route
topical
Published
Effective Date 2020-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (3.059 mL)
Inactive Ingredients
dexpanthenol peg-7 glyceryl cocoate edetic acid anhydrous citric acid water polysorbate 20 cocamidopropyl betaine lemon oil, distilled glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-16

Purpose

Antiseptic- Antibacterial hand towelettes

Description

Ethyl Alcohol (Ethanol) 70%


Medication Information

Warnings

For external use only, do not ingest. Do not use near eyes. Keep away from flame and direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

Purpose

Antiseptic- Antibacterial hand towelettes

Inactive Ingredients

Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA

Description

Ethyl Alcohol (Ethanol) 70%

Use

Wipes used on hands and skin to reduce bacteria

Section 50565-1

Store in places out of reach of children. Supervise use by children under the age of 6.

Storage

Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

Stop Use

Stop use if redness, irritation, or rash occurs.

Dierctions

Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use

Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.

When Using

If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.

Package Label

120 Count Canister: 78141-211-12

200 Count Canister: 78141-211-20

500 Count Canister: 78141-211-50

Active Ingredient

Ethyl Alcohol (Ethanol) 70%


Structured Label Content

Warnings

For external use only, do not ingest. Do not use near eyes. Keep away from flame and direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

Purpose

Antiseptic- Antibacterial hand towelettes

Inactive Ingredients

Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA

Use

Wipes used on hands and skin to reduce bacteria

Section 50565-1 (50565-1)

Store in places out of reach of children. Supervise use by children under the age of 6.

Storage

Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

Stop Use

Stop use if redness, irritation, or rash occurs.

Dierctions

Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use

Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.

When Using

If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.

Package Label

120 Count Canister: 78141-211-12

200 Count Canister: 78141-211-20

500 Count Canister: 78141-211-50

Active Ingredient

Ethyl Alcohol (Ethanol) 70%


Advanced Ingredient Data


Raw Label Data

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