Planeaire Hands Gel Lemon Carrotseed Hand Sanitizer

Planeaire Hands Gel Lemon Carrotseed Hand Sanitizer
SPL v2
SPL
SPL Set ID b68a5d56-1a0d-755c-e053-2995a90a3954
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Green Tea Leaf Lemon Oil Carrot Seed Oil Carbomer 980 Sodium Hydroxide Glycerin Aloe Vera Leaf Polysaccharides Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL 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 Sterile distilled water or boiled cold 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 Sterile distilled water or boiled cold 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
  • Sterile distilled water or boiled cold 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 rash occurs. If conditon persists for more than 72 hours, consult a doctor

Section 50567-7

In case of contact with eyes, rinse eyes thoroughly with water.



Stop use if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor



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 wounds or near eyes.
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 vera inner leaf, green tea extract, carbomer, glycerin, lemon oil, carrot seed oil, sodium hydroxide, water

Dosage and Administration 12/20

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

60 mL NDC: 80335-106-02


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
  • Sterile distilled water or boiled cold 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 rash occurs. If conditon persists for more than 72 hours, consult a doctor

Section 50567-7 (50567-7)

In case of contact with eyes, rinse eyes thoroughly with water.



Stop use if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor



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 wounds or near eyes.
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 vera inner leaf, green tea extract, carbomer, glycerin, lemon oil, carrot seed oil, sodium hydroxide, water

Dosage and Administration 12/20

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: 80335-106-02


Advanced Ingredient Data


Raw Label Data

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