Planeaire Hands Spray Hand Sanitizer Signature Herbal

Planeaire Hands Spray Hand Sanitizer Signature Herbal
SPL v3
SPL
SPL Set ID b6af3009-78c2-2312-e053-2995a90af90a
Route
TOPICAL
Published
Effective Date 2020-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Polysaccharides Glycerin Lemon Oil Thyme Oil Rosemary Oil Green Tea Leaf Lavender Oil Oregano Leaf Oil Carbomer 980 Water Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-21

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol. Sodium hydroxide Water. other Inactive ingredients

Purpose

Antiseptic, Hand Sanitizer

Dosage and Administration

Wet hands thoroughly with product, rub hands, and allow to dry without wiping. For children under 6 years of age, use only under adult supervision to avoid swallowing. not recommended for infants


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Dosage and Administration

Wet hands thoroughly with product, rub hands, and allow to dry without wiping.

For children under 6 years of age, use only under adult supervision to avoid swallowing.

not recommended for infants

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol. Sodium hydroxide Water. other Inactive ingredients

Use

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

Section 42229-5

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol.
  • Sodium hydroxide
  • Water.
  • other Inactive ingredients
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 if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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.

Warnings

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

Directions
  • Wet hands thoroughly with product, rub hands, and allow to dry without wiping.
  • For children under 6 years of age, use only under adult supervision to avoid swallowing.
  • not recommended for infants
Do Not Use
  • on open skin wounds or near eyes. In case of contact with eyes, rinse thoroughly with water
Other Information
  • store between 15-30C (59-86F)
  • do not store above 105F
  • Avoid freezing
  • may discolor some fabrics
  • may be harmful to some wood finishes and plastics
Active Ingredient(s)

Alcohol 70% v/v.

Inactive Ingredients

aloe inner leaf, green tea extract, glycerin, Carbomer, lavender oil, lemon oil, oregano oil, peppermint oil, rosemary oil, thyme oil, water

Package Label Principal Display Panel

60 mL NDC: 80335-105-02


Structured Label Content

Use

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

Section 42229-5 (42229-5)

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol.
  • Sodium hydroxide
  • Water.
  • other Inactive ingredients
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 if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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

Warnings

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

Directions
  • Wet hands thoroughly with product, rub hands, and allow to dry without wiping.
  • For children under 6 years of age, use only under adult supervision to avoid swallowing.
  • not recommended for infants
Do Not Use (Do not use)
  • on open skin wounds or near eyes. In case of contact with eyes, rinse thoroughly with water
Other Information (Other information)
  • store between 15-30C (59-86F)
  • do not store above 105F
  • Avoid freezing
  • may discolor some fabrics
  • may be harmful to some wood finishes and plastics
Active Ingredient(s)

Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

aloe inner leaf, green tea extract, glycerin, Carbomer, lavender oil, lemon oil, oregano oil, peppermint oil, rosemary oil, thyme oil, water

Dosage and Administration

Wet hands thoroughly with product, rub hands, and allow to dry without wiping.

For children under 6 years of age, use only under adult supervision to avoid swallowing.

not recommended for infants

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

60 mL NDC: 80335-105-02


Advanced Ingredient Data


Raw Label Data

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