SPL v2
SPL
SPL Set ID 4a70eac0-f696-3f8c-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mL)
Inactive Ingredients
Fd&c Yellow No. 5 Lavandula Angustifolia Whole Water Carbomer 940 Glycerin Aloe Vera Leaf .alpha.-tocopherol Acetate D&c Red No. 33 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-03-11

Description

Active Ingredients Ethyl Alcohol 70%


Medication Information

Warnings and Precautions

Warnings

Flammable

Indications and Usage

Use hand sanitizer to help reduce bacteria on the skin

Dosage and Administration

Directions

  • apply palmful to hands
    • rub hands together vigorously until dry
    • supervise children in the use of this product
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 50567-7

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

Section 51727-6

Water, Carbomer, Trethanolamine, Glycerin, Propylene Glycol, Alo Barbdensis Leaf Juice*, Tocopherol Acetate*, Lavandula Angustifolia Flower / Leaf / Stem Extract*, Fragrance*, D&C Red # 33*, FD&C Blue # 1*, FD&C Yellow # 5*,

* Contains 1 or more of these ingredients

Section 51945-4

​SpaSoap

Hand Sanitizer

2fl.oz (59ml) Each

6 fl.oz (177ml) Total

Section 55105-1

Purpose - Antiseptic

Section 55106-9

Active Ingredients

Ethyl Alcohol 70%

Section 59845-8

For external use only

Section 60561-8

Keep away from fire or flame


Structured Label Content

Indications and Usage (34067-9)

Use hand sanitizer to help reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • apply palmful to hands
    • rub hands together vigorously until dry
    • supervise children in the use of this product
Warnings and Precautions (34071-1)

Warnings

Flammable

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 50567-7 (50567-7)

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Water, Carbomer, Trethanolamine, Glycerin, Propylene Glycol, Alo Barbdensis Leaf Juice*, Tocopherol Acetate*, Lavandula Angustifolia Flower / Leaf / Stem Extract*, Fragrance*, D&C Red # 33*, FD&C Blue # 1*, FD&C Yellow # 5*,

* Contains 1 or more of these ingredients

Section 51945-4 (51945-4)

​SpaSoap

Hand Sanitizer

2fl.oz (59ml) Each

6 fl.oz (177ml) Total

Section 55105-1 (55105-1)

Purpose - Antiseptic

Section 55106-9 (55106-9)

Active Ingredients

Ethyl Alcohol 70%

Section 59845-8 (59845-8)

For external use only

Section 60561-8 (60561-8)

Keep away from fire or flame


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)