b46c2054-8acd-3d3a-e053-2a95a90a3af7

SPL v1
SPL
SPL Set ID b46c2054-8acd-3d3a-e053-2a95a90a3af7
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lavandula angustifolia flower (0.0002 g) benzalkonium (0.13 g) cymbopogon citratus leaf eucalyptus oil
Inactive Ingredients
quillaja saponaria bark glycerin water

Identifiers & Packaging

Marketing Status
multi-market approved product active Since 2020-03-30

Description

This is a sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . 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: .13% Benzalklonium Chloride 1.75% citric acid <1% lemongrass <1% eucalyptus <1% lavender The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.


Medication Information

Warnings

For external use only. Non flammable.

Directions
  • Place enough product on hands to cover all surfaces. Let dry.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

glycerin, soap bark extract, purified water USP

Description

This is a sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . 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: .13% Benzalklonium Chloride 1.75% citric acid <1% lemongrass <1% eucalyptus <1% lavender The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

Sanitizer to help reduce bacteria that potentially can cause disease.

Section 42229-5

This is a sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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:

  • .13% Benzalklonium Chloride
  • 1.75% citric acid
  • <1% lemongrass
  • <1% eucalyptus
  • <1% lavender

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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.

Section 55105-1

Antiseptic, Antimiicrobial

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

Benzalklonium Chloride, citric acid

Package Label Principal Display Panel

NDC Code: 80743-151-32

NDC Code: 80743-151-17


Structured Label Content

Warnings

For external use only. Non flammable.

Directions
  • Place enough product on hands to cover all surfaces. Let dry.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

glycerin, soap bark extract, purified water USP

Use

Sanitizer to help reduce bacteria that potentially can cause disease.

Section 42229-5 (42229-5)

This is a sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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:

  • .13% Benzalklonium Chloride
  • 1.75% citric acid
  • <1% lemongrass
  • <1% eucalyptus
  • <1% lavender

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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.

Section 55105-1 (55105-1)

Antiseptic, Antimiicrobial

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

Benzalklonium Chloride, citric acid

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

NDC Code: 80743-151-32

NDC Code: 80743-151-17


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)