baby wipes

baby wipes
SPL v2
SPL
SPL Set ID aef07b16-36f6-19de-e053-2a95a90a5c70
Route
topical
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.03 g)
Inactive Ingredients
citric acid monohydrate bronopol propylene glycol water polysorbate 20 poliglusam

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-09-09

Purpose

Antiseptic

Description

Benzalkonium Chloride


Medication Information

Warnings
  • For external use only.
  • Highly Flammable - Keep away from fire or flame.
Purpose

Antiseptic

Directions
  • Wipe hands, discard properly in trash receptacle.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store at room temperature. Do not store above 105℉.
  • Do not freeze
  • May discolor some fabrics. Harmful to wood finishes and plastics.
  • Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.
Inactive Ingredients

2-Bromo-2-nitro-1,3-propanediol, Chitosan, Polysorbate 20, Propylene Glycol, Citric Acid, Purified Water.

Description

Benzalkonium Chloride

Use

For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

Section 50565-1

Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

Section 50566-9

Stop use and ask a doctor if skin irritation or rash occurs.

Section 50567-7
  • Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
  • Avoid contact with broken skin. Do not inhale or ingest.
Do Not Use
  • On open skin wounds.
Active Ingredient(s)

Benzalkonium Chloride

Package Label Principal Display Panel

NDC:54016-005-01 60PCS

NDC:54016-005-02 1PCS

NDC:54016-005-03 10PCS

NDC:54016-005-04 15PCS

NDC:54016-005-05 20PCS

NDC:54016-005-06 25PCS

NDC:54016-005-07 30PCS

NDC:54016-005-08 40PCS

NDC:54016-005-09 50PCS

NDC:54016-005-10 80PCS

NDC:54016-005-11 90PCS

NDC:54016-005-12 100PCS

NDC:54016-005-13 120PCS

NDC:54016-005-14 150PCS


Structured Label Content

Warnings
  • For external use only.
  • Highly Flammable - Keep away from fire or flame.
Purpose

Antiseptic

Directions
  • Wipe hands, discard properly in trash receptacle.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store at room temperature. Do not store above 105℉.
  • Do not freeze
  • May discolor some fabrics. Harmful to wood finishes and plastics.
  • Effective at eliminating more than 99.99% of many common harmful germs and bacteriain as little as 15 seconds.
Inactive Ingredients (Inactive ingredients)

2-Bromo-2-nitro-1,3-propanediol, Chitosan, Polysorbate 20, Propylene Glycol, Citric Acid, Purified Water.

Use

For hand sanitizing that helps reduce bacteria on the skin, recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, contact a Poison Control Center or a doctor.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation or rash occurs.

Section 50567-7 (50567-7)
  • Avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush with water.
  • Avoid contact with broken skin. Do not inhale or ingest.
Do Not Use (Do not use)
  • On open skin wounds.
Active Ingredient(s)

Benzalkonium Chloride

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

NDC:54016-005-01 60PCS

NDC:54016-005-02 1PCS

NDC:54016-005-03 10PCS

NDC:54016-005-04 15PCS

NDC:54016-005-05 20PCS

NDC:54016-005-06 25PCS

NDC:54016-005-07 30PCS

NDC:54016-005-08 40PCS

NDC:54016-005-09 50PCS

NDC:54016-005-10 80PCS

NDC:54016-005-11 90PCS

NDC:54016-005-12 100PCS

NDC:54016-005-13 120PCS

NDC:54016-005-14 150PCS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)