SPL v1
SPL
SPL Set ID aeafa80e-701f-225c-e053-2995a90a1821
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (3.059 mL)
Inactive Ingredients
Peg-7 Glyceryl Cocoate Edetic Acid Polysorbate 20 Cocamidopropyl Betaine Dexpanthenol Glycerin Lemon Oil, Distilled Anhydrous Citric Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-07

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Use

Wipes used on hands and skin to reduce bacteria

Section 43683-2

Changed the pre-filled out section for "Use"

Changed the pre-filled out section for "Directions"

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Supervise use by children under the age of 6.

Section 50567-7

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



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



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage

  • Avoid freezing and excessive heat above 40C (104F)
  • Store away from direct sunlight
  • Store tightly closed in its original packaging
  • Keep away from food, drinks, and animal feed
  • Store in places unaccessible to children
Stop Use

Stop use and ask a doctor if irritation or rash occurs and persists for longer than 72 hours. These may be signs of a serious condition.

Warnings

For external use only, do not ingest. Flammable. Keep away from heat, flame, or 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.

Directions
  • Peel back open label slowly
  • Pull out one wipe at a time
  • Reseal packaging tightly
  • Wet hands thoroughly with product and allow to dry
  • Supervise children under 6 years of age when using this product to avoid ingestion
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
  • near eyes
Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

lemon oil-distilled, peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, water, polysorbate 20, cocamidopropyl betaine, dexpanthenol, glycerin

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

120 Count Canister NDC: 90083-211-12

200 Count Canister NDC: 90083-211-20

500 Count Canister NDC: 90083-211-50


Structured Label Content

Use

Wipes used on hands and skin to reduce bacteria

Section 43683-2 (43683-2)

Changed the pre-filled out section for "Use"

Changed the pre-filled out section for "Directions"

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Supervise use by children under the age of 6.

Section 50567-7 (50567-7)

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



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



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Storage

  • Avoid freezing and excessive heat above 40C (104F)
  • Store away from direct sunlight
  • Store tightly closed in its original packaging
  • Keep away from food, drinks, and animal feed
  • Store in places unaccessible to children
Stop Use

Stop use and ask a doctor if irritation or rash occurs and persists for longer than 72 hours. These may be signs of a serious condition.

Warnings

For external use only, do not ingest. Flammable. Keep away from heat, flame, or 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.

Directions
  • Peel back open label slowly
  • Pull out one wipe at a time
  • Reseal packaging tightly
  • Wet hands thoroughly with product and allow to dry
  • Supervise children under 6 years of age when using this product to avoid ingestion
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
  • near eyes
Active Ingredient

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

lemon oil-distilled, peg-7 glyceryl cocoate, edetic acid, anhydrous citric acid, water, polysorbate 20, cocamidopropyl betaine, dexpanthenol, glycerin

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

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

120 Count Canister NDC: 90083-211-12

200 Count Canister NDC: 90083-211-20

500 Count Canister NDC: 90083-211-50


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)