SPL v1
SPL
SPL Set ID a983fd02-a997-2466-e053-2a95a90a1a74
Route
TOPICAL
Published
Effective Date 2020-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 mL)
Inactive Ingredients
Water Trolamine Carbomer Homopolymer, Unspecified Type Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-03

Description

Store between 15- 30°C (59-86°F)


Medication Information

Warnings and Precautions

1.For extermal use only.

2.Do not use in children less than 2 months of age.

3.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

4.Stop use and ask a doctor if iritation or rash occurs. This may be signs of a serious condition.

5.Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.

Indications and Usage

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Dosage and Administration

Store between 15- 30°C (59-86°F)

Description

Store between 15- 30°C (59-86°F)

Section 50565-1

keep out of reach of children

Section 51727-6

Purified Water USP, Triethanolamine,Carbomer,Glycerin

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Alcohol


Structured Label Content

Indications and Usage (34067-9)

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Dosage and Administration (34068-7)

Store between 15- 30°C (59-86°F)

Warnings and Precautions (34071-1)

1.For extermal use only.

2.Do not use in children less than 2 months of age.

3.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

4.Stop use and ask a doctor if iritation or rash occurs. This may be signs of a serious condition.

5.Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Purified Water USP, Triethanolamine,Carbomer,Glycerin

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)