Planeaire Hands Lemongrass Rosemary Gel Aloe Green Tea

Planeaire Hands Lemongrass Rosemary Gel Aloe Green Tea
SPL v3
SPL
SPL Set ID b6996b39-752c-e26a-e053-2a95a90ad7fe
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
Rosemary Oil Carbomer 980 East Indian Lemongrass Oil Aloe Vera Leaf Polysaccharides Green Tea Leaf Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-21

Description

The hand sanitizer is manufactured using only the following 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 Water. Other inactive ingredients.

Purpose

Antiseptic,


Medication Information

Purpose

Antiseptic,

Description

The hand sanitizer is manufactured using only the following 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 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 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
  • 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 occurs. If condition persists for more than 72 hours, consult a doctor.

Section 50567-7

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



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



Keep out of reach of children. If swallowed, get medical help or contact a local 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 no store above 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, lemongrass oil blend, rosemary oil, carbomer, glycerin, sodium hydroxide, water

Package Label Principal Display Panel

60 mL NDC: 80335-113-02


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 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
  • 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 occurs. If condition persists for more than 72 hours, consult a doctor.

Section 50567-7 (50567-7)

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



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



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

Purpose

Antiseptic,

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 no store above 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, lemongrass oil blend, rosemary oil, carbomer, glycerin, sodium hydroxide, water

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

60 mL NDC: 80335-113-02


Advanced Ingredient Data


Raw Label Data

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