SPL v1
SPL
SPL Set ID aa92fb87-9cda-ee8c-e053-2a95a90a1c30
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Citric Acid Acetate Matricaria Chamomilla Lavender Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-26

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic Sanitizer


Medication Information

Purpose

Antiseptic Sanitizer

Description

Benzalkonium Chloride 0.13%

Use

For hand sanitizing to help reduce bacteria on skin. Recommended for repeated use.

Warnings

For external use only. Do not spray in the eyes.

  • When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
  • Stop use and ask a doctor if redness or irritation occurs and persist for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN
Directions

Directions

Read the entire label before using this product.

Apply liberally to the hands and rub together until dry.

Active Ingredient

Benzalkonium Chloride 0.13%

4 L Ndc 79851 019 05

Inactive Ingredients

Aqua, Glycerin, Citric Acid, Matricaria (Chamomilla Recutita) Flower Extract, Lavender (Lavandula Angustifolia) Extract, Aloe Barbadensis Leaf Juice

25 Ml Ndc 79851 019 01

50 Ml Ndc 79851 019 03

210 Ml Ndc 79851 019 09

Keep Out of Reach of Children

Children should be supervised when using this product.


Structured Label Content

Use

For hand sanitizing to help reduce bacteria on skin. Recommended for repeated use.

Purpose

Antiseptic Sanitizer

Warnings

For external use only. Do not spray in the eyes.

  • When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
  • Stop use and ask a doctor if redness or irritation occurs and persist for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN
Directions

Directions

Read the entire label before using this product.

Apply liberally to the hands and rub together until dry.

Active Ingredient

Benzalkonium Chloride 0.13%

4 L Ndc 79851 019 05 (4 L NDC 79851-019-05)

Inactive Ingredients

Aqua, Glycerin, Citric Acid, Matricaria (Chamomilla Recutita) Flower Extract, Lavender (Lavandula Angustifolia) Extract, Aloe Barbadensis Leaf Juice

25 Ml Ndc 79851 019 01 (25 ml NDC 79851-019-01)

50 Ml Ndc 79851 019 03 (50 ml NDC 79851-019-03)

210 Ml Ndc 79851 019 09 (210 ml NDC 79851-019-09)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Children should be supervised when using this product.


Advanced Ingredient Data


Raw Label Data

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