47993-296

47993-296
SPL v2
SPL
SPL Set ID cefc45fe-67e2-4389-8d4d-aee969ee5a39
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Propanediol .alpha.-tocopherol Acetate Aloe Vera Leaf Aminomethylpropanol Jojoba Oil Sunflower Oil Cranberry Juice Punica Granatum Leaf Vaccinium Angustifolium Leaf Fragaria Vesca Leaf Kiwi Fruit

Identifiers & Packaging

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

Description

Active ingredients Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

Warnings:

For external use only. Flammable.

Keep away from heat or flame.

Indications and Usage

Uses:

Hand sanitizer can help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

Directions:

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Surpervise children under 6 years of age when using this product to avoid swallowing.
Description

Active ingredients Ethyl Alcohol 70%

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.

Section 50570-1

Do not use:

  • In children less than 2 months of age.
  • On open skin wounds.
Section 51727-6

Inactive Ingredients:

Ethyl Alcohol, Water, Glycerin, Propylene glycol, Propanediol, Tocopheryl acetate, Aloe barbadensis leaf juice, Aminomethyl propanol, Simmondsia chinensis (jojoba) seed oil, Helianthus annuus (sunflower) seed oil, Vaccinium macrocarpon (cranberry) fruit extract, Punica granatum extract, Vaccinium angustifolium (blueberry) fruit extract, Fragaria chiloensis ( strawberry) fruit extract, Actinidia chinesis (kiwi) fruit extract.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 70%

Section 60561-8

Other info:

  • Store between 15-30℃(59-86℉)
  • Avoid freezing and excessive heat above 40℃(104℉)

Structured Label Content

Indications and Usage (34067-9)

Uses:

Hand sanitizer can help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Directions:

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Surpervise children under 6 years of age when using this product to avoid swallowing.
Warnings and Precautions (34071-1)

Warnings:

For external use only. Flammable.

Keep away from heat or flame.

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.

Section 50570-1 (50570-1)

Do not use:

  • In children less than 2 months of age.
  • On open skin wounds.
Section 51727-6 (51727-6)

Inactive Ingredients:

Ethyl Alcohol, Water, Glycerin, Propylene glycol, Propanediol, Tocopheryl acetate, Aloe barbadensis leaf juice, Aminomethyl propanol, Simmondsia chinensis (jojoba) seed oil, Helianthus annuus (sunflower) seed oil, Vaccinium macrocarpon (cranberry) fruit extract, Punica granatum extract, Vaccinium angustifolium (blueberry) fruit extract, Fragaria chiloensis ( strawberry) fruit extract, Actinidia chinesis (kiwi) fruit extract.

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 info:

  • Store between 15-30℃(59-86℉)
  • Avoid freezing and excessive heat above 40℃(104℉)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)