SPL v1
SPL
SPL Set ID a46b6578-b5d6-bcfe-e053-2995a90ac27e
Route
EXTRACORPOREAL
Published
Effective Date 2020-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (307.45 mL)
Inactive Ingredients
Fd&c Yellow No. 5 D&c Red No. 33 Fd&c Red No. 4 Trolamine Glycerin Fd&c Blue No. 1 Fragrance Lavender & Chia F-153480 Water Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-29

Description

1.Store below 15 30C (59 86F). 2.Avoid feezing and exessve heat above 40C (104F).


Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame Do not use in cildren less than2 months of age .on open skin woundsWhen using this product keep out of eye,ears, and mouth. In case of contat with eyes, rinse thoroughly with water.

Stop use and ask a doctor if itationo or rash ocus. These moy be signs of a senious condition.Keep gut of reach of children. If sollowed, get medical help or contorl Poison Control Center right away.

Indications and Usage

1.Place enough poducton bonds to cover a sufare. Rub honds together unil dry.

2.Supervise Cildren under 6 years of age when using this produdt to avoid.

Dosage and Administration

1.Store below 15 30C (59 86F).

2.Avoid feezing and exessve heat above 40C (104F).

Description

1.Store below 15 30C (59 86F). 2.Avoid feezing and exessve heat above 40C (104F).

Section 50565-1

keep out of reach of children

Section 51727-6

WATER

GLYCERIN

CARBOMER

TRIETHANOLAMINE

FRAGRANCE

1) FD&C RED NO.4 (CI14700)

2) FD&C YELLOW NO.5 (CI19140)

3) FD&C BLUE NO.1 (CI42090)

4) D&C RED NO.33 (CI17200)

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 poducton bonds to cover a sufare. Rub honds together unil dry.

2.Supervise Cildren under 6 years of age when using this produdt to avoid.

Dosage and Administration (34068-7)

1.Store below 15 30C (59 86F).

2.Avoid feezing and exessve heat above 40C (104F).

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame Do not use in cildren less than2 months of age .on open skin woundsWhen using this product keep out of eye,ears, and mouth. In case of contat with eyes, rinse thoroughly with water.

Stop use and ask a doctor if itationo or rash ocus. These moy be signs of a senious condition.Keep gut of reach of children. If sollowed, get medical help or contorl Poison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

WATER

GLYCERIN

CARBOMER

TRIETHANOLAMINE

FRAGRANCE

1) FD&C RED NO.4 (CI14700)

2) FD&C YELLOW NO.5 (CI19140)

3) FD&C BLUE NO.1 (CI42090)

4) D&C RED NO.33 (CI17200)

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)