47993-278

47993-278
SPL v2
SPL
SPL Set ID b82ffb83-25fe-40f6-b453-88ca62b8f71d
Route
TOPICAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-18

Description

Active ingredients Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

Warnings:

  • Flammable. 
  • Keep away from fire or flame.
  • For external use only.
Indications and Usage

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration

Directions:

  • Squeeze small amount in your palm and briskly rub hands together, and allow to air dry.
  • For children under 6, use with adult supervision. Not recommended for infants.
Description

Active ingredients Ethyl Alcohol 70%

Section 50565-1
  • Keep out of reach of children.
Section 50566-9
  • Stop use and ask a doctor if irritation or redness develops.
Section 50567-7
  • Keep away from eyes.
  • Do not inhale or ingest.
Section 51727-6

Inactive Ingredients:

Water,Carbomer 940,triethanolamine,Glycerin,Aloe Barbadensis

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 70%

Section 60561-8

Other information:

  • Store below 110℉(43℃)
  • May discolor certain fabrics or surfaces.


Structured Label Content

Indications and Usage (34067-9)

Uses:

For hand sanitizing to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions:

  • Squeeze small amount in your palm and briskly rub hands together, and allow to air dry.
  • For children under 6, use with adult supervision. Not recommended for infants.
Warnings and Precautions (34071-1)

Warnings:

  • Flammable. 
  • Keep away from fire or flame.
  • For external use only.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if irritation or redness develops.
Section 50567-7 (50567-7)
  • Keep away from eyes.
  • Do not inhale or ingest.
Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Carbomer 940,triethanolamine,Glycerin,Aloe Barbadensis

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 70%

Section 60561-8 (60561-8)

Other information:

  • Store below 110℉(43℃)
  • May discolor certain fabrics or surfaces.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)