47993-295

47993-295
SPL v3
SPL
SPL Set ID 95551a96-60e9-426d-9241-153f6c0b552b
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Carbomer 940 Triethanolamine Benzoate Glycerin Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-10

Description

Active ingredients Alcohol 70% V/V


Medication Information

Warnings and Precautions

Warnings:

  • For external use only*Flammable*Keep away from fire or flame. 
  • Do not store above 40℃ (105℉).
Indications and Usage

Uses: 

  • Hand sanitizer to help decrease bacteria on skin.
  • When water, soap are not available.
  • Recommended for repeated use.
Dosage and Administration

Directions:

  • Pump as needed into your palms and spread on both hands.
  • Rub into skin until dry.
  • Children under 6 years should be supervisd when using this product.
Description

Active ingredients Alcohol 70% V/V

Section 50565-1

Keep out of reach of children.

Children must be supervised in use of this product.

Section 50566-9
  • Stop use and seek 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.
Section 50570-1
  • Do not use in mouth, ears or eyes.
Section 51727-6

Inactive Ingredients:

Water,Carbomer940,Triethanolamine,Glycerin,Aloe Barbadensis.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Alcohol 70% V/V

Section 60561-8

Other information:

  • Store below 106℉(41℃)
  • May discolor fabrics

Structured Label Content

Indications and Usage (34067-9)

Uses: 

  • Hand sanitizer to help decrease bacteria on skin.
  • When water, soap are not available.
  • Recommended for repeated use.
Dosage and Administration (34068-7)

Directions:

  • Pump as needed into your palms and spread on both hands.
  • Rub into skin until dry.
  • Children under 6 years should be supervisd when using this product.
Warnings and Precautions (34071-1)

Warnings:

  • For external use only*Flammable*Keep away from fire or flame. 
  • Do not store above 40℃ (105℉).
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 seek 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.
Section 50570-1 (50570-1)
  • Do not use in mouth, ears or eyes.
Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Carbomer940,Triethanolamine,Glycerin,Aloe Barbadensis.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Alcohol 70% V/V

Section 60561-8 (60561-8)

Other information:

  • Store below 106℉(41℃)
  • May discolor fabrics

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)