SPL v1
SPL
SPL Set ID a4032ce4-52aa-f5a2-e053-2a95a90a6131
Route
EXTRACORPOREAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (262.5 mL)
Inactive Ingredients
.alpha.-tocopherol Acetate Aloe Vera Leaf 3-hexenyl Salicylate, Cis- D&c Red No. 33 Trolamine Sodium Sulfite Ext. D&c Violet No. 2 Propionaldehyde Sodium Benzoate Water Citric Acid Monohydrate Potassium Sorbate Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-24

Description

Store at room temperature 20*. 25°C (66*F-77*F)


Medication Information

Warnings and Precautions

1.Flammable, keep away from fire or flame.

2.For external use only

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

4.Stop use and ask a doctor if redness or rritation or rash appears and persists for more than 72 hours.

5.Keep out of reach of children. If swallowed, get medical help or contact the Poison Control center right away.

Indications and Usage

1.Place enough product in your palm to thoroughly cover your hands

2.Rub hands together briskly until dry●No rinsing required

3.No towels needed●Do not use other than directed.

Dosage and Administration

Store at room temperature 20*. 25°C (66*F-77*F)

Description

Store at room temperature 20*. 25°C (66*F-77*F)

Section 50565-1

keep out of children

Section 51727-6

Aqua, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Jojoba Wax PEG-120 Esters, Aloe Barbadensis Leaf Extract, Citric Acid, Sodium Benzoate, Potassium Sorbate, Sodium Sulfite, CI 19140, CI 60730, CI 17200, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran,α-methyl-1,3-benzodioxole-5-propionaldehyde, (Z)-3-hexenyl salicylate.

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

1.Place enough product in your palm to thoroughly cover your hands

2.Rub hands together briskly until dry●No rinsing required

3.No towels needed●Do not use other than directed.

Dosage and Administration (34068-7)

Store at room temperature 20*. 25°C (66*F-77*F)

Warnings and Precautions (34071-1)

1.Flammable, keep away from fire or flame.

2.For external use only

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

4.Stop use and ask a doctor if redness or rritation or rash appears and persists for more than 72 hours.

5.Keep out of reach of children. If swallowed, get medical help or contact the Poison Control center right away.

Section 50565-1 (50565-1)

keep out of children

Section 51727-6 (51727-6)

Aqua, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Jojoba Wax PEG-120 Esters, Aloe Barbadensis Leaf Extract, Citric Acid, Sodium Benzoate, Potassium Sorbate, Sodium Sulfite, CI 19140, CI 60730, CI 17200, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran,α-methyl-1,3-benzodioxole-5-propionaldehyde, (Z)-3-hexenyl salicylate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)