a42b8e7c-b05a-9d47-e053-2a95a90a69dc

SPL v4
SPL
SPL Set ID a42b8e7c-b05a-9d47-e053-2a95a90a69dc
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
carbomer 980 glycerin propylene glycol water trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-03-20

Purpose

Antiseptic, Hand Sanitizer

Description

NA


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

purified water,glycerin, propylene glycol,carbomer,triethanolamine

Description

NA

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease

Section 42229-5

NA

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.

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

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

29 mL NDC: 74765-004-01

50mL NDC: 74765-004-02

60 mL NDC: 74765-004-03

100 mL NDC: 74765-004-04

300 mL NDC: 74765-004-05

500 mL NDC: 74765-004-06

1000 mL NDC: 74765-004-07

2000 mL NDC: 74765-004-08

3000 mL NDC: 74765-004-09

5000 mL NDC: 74765-004-10

80 mL NDC: 74765-004-11

236mL NDC:74465-004-12


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

purified water,glycerin, propylene glycol,carbomer,triethanolamine

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease

Section 42229-5 (42229-5)

NA

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.

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

Alcohol 75% v/v. Purpose: Antiseptic

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

29 mL NDC: 74765-004-01

50mL NDC: 74765-004-02

60 mL NDC: 74765-004-03

100 mL NDC: 74765-004-04

300 mL NDC: 74765-004-05

500 mL NDC: 74765-004-06

1000 mL NDC: 74765-004-07

2000 mL NDC: 74765-004-08

3000 mL NDC: 74765-004-09

5000 mL NDC: 74765-004-10

80 mL NDC: 74765-004-11

236mL NDC:74465-004-12


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)