new nb gel

new nb gel
SPL v2
SPL
SPL Set ID a611188f-90f7-0cd0-e053-2995a90a9a55
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
propylene glycol aminomethylpropanol alpha-tocopherol acetate glycerin carbomer homopolymer, unspecified type water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-15

Purpose

Antiseptic, Hand Sanitizer

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic


Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using products.
Other Information
  • Store below 110°F(43C°)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

Aqua (water), Glycerin, Propylene Glycol, Carbopol, Aminomethyl Propanol, Tocopheryl Acetate

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50566-9

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

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.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

50 ml NDC: 78068-123-50


Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using products.
Other Information (Other information)
  • Store below 110°F(43C°)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Aqua (water), Glycerin, Propylene Glycol, Carbopol, Aminomethyl Propanol, Tocopheryl Acetate

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. 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 or rash occurs. These may be signs of a serious condition.

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.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

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

50 ml NDC: 78068-123-50


Advanced Ingredient Data


Raw Label Data

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