SPL v11
SPL
SPL Set ID a4e4617e-9ed2-1861-e053-2995a90a3971
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Propylene Glycol Carbomer 980 Glycerin Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

NA

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

NA

Use

Hand Sanitizer to help decrease bacteria on skin. when water, soap& towel are not available. recommended for repeated use.

Section 42229-5

NA

Section 50565-1



Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9



Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Section 50567-7

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 develop and persist for more than 72 hours.



Keep out of reach of children. Children must be supervised in use of this product.

Warnings

For external use only: hands. Flammable. Keep away from fire or flame

Directions

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision,

not recommended for infants

Do Not Use
  • Do not apply around eyes.Do not use in ears&mouth
Other Information



store between 59-86F (15~30C) ,may discolor some fabrics, harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

water, propylene glycol,glycerin, carbomer.triethanolamine

Package Label Principal Display Panel

50 mL NDC: 74765-011-01

150 mL NDC: 74765-011-02

236 mL NDC: 74765-011-03

500 mL NDC: 74765-011-04


Structured Label Content

Use

Hand Sanitizer to help decrease bacteria on skin. when water, soap& towel are not available. recommended for repeated use.

Section 42229-5 (42229-5)

NA

Section 50565-1 (50565-1)



Keep out of reach of children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)



Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

Section 50567-7 (50567-7)

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 develop and persist for more than 72 hours.



Keep out of reach of children. Children must be supervised in use of this product.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only: hands. Flammable. Keep away from fire or flame

Directions

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision,

not recommended for infants

Do Not Use (Do not use)
  • Do not apply around eyes.Do not use in ears&mouth
Other Information (Other information)



store between 59-86F (15~30C) ,may discolor some fabrics, harmful to wood finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

water, propylene glycol,glycerin, carbomer.triethanolamine

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

50 mL NDC: 74765-011-01

150 mL NDC: 74765-011-02

236 mL NDC: 74765-011-03

500 mL NDC: 74765-011-04


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)