78565-005

78565-005
SPL v1
SPL
SPL Set ID b7405ace-1293-45f6-e053-2995a90a0cc9
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Trolamine Aloe Vera Leaf .alpha.-tocopherol Succinate, D- Glycerin Carbomer Homopolymer, Unspecified Type Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial


Medication Information

Indications and Usage

Hand sanitizer to help reduce bacteria on skin.

Purpose

Antimicrobial

Description

Ethyl Alcohol 75% v/v

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Directions

Put enough product in your palm to cover hands and rubands together briskly until dry.

Children under 6 years of age should be supervised when using.

Do Not Use

do not use in or near the eyes.

Other Information

Store below 110°F(43°C)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Water, Glycerin, Carbomer, Aloe Vera, Trithanolamine, Vitamine E

Package Label Principal Display Panel

30ml 78565-005-05

30ml 78565-005-08

30ml 78565-005-15

30ml 78565-005-18

30ml 78565-005-25

30ml 78565-005-35

30ml 78565-005-45

30ml 78565-005-55

30ml 78565-005-65

30ml 78565-005-75

30ml 78565-005-85

30ml 78565-005-95

59ml 78565-005-04

59ml 78565-005-14

59ml 78565-005-24

59ml 78565-005-34

59ml 78565-005-44

59ml 78565-005-54

59ml 78565-005-64

100ml 78565-005-02

100ml 78565-005-12

227ml 78565-005-06

227ml 78565-005-16

236ml 78565-005-07

236ml 78565-005-17


Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce bacteria on skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Purpose

Antimicrobial

Directions

Put enough product in your palm to cover hands and rubands together briskly until dry.

Children under 6 years of age should be supervised when using.

Do Not Use (Do not use)

do not use in or near the eyes.

Other Information (Other information)

Store below 110°F(43°C)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Aloe Vera, Trithanolamine, Vitamine E

Package Label Principal Display Panel (Package Label - Principal Display Panel)

30ml 78565-005-05

30ml 78565-005-08

30ml 78565-005-15

30ml 78565-005-18

30ml 78565-005-25

30ml 78565-005-35

30ml 78565-005-45

30ml 78565-005-55

30ml 78565-005-65

30ml 78565-005-75

30ml 78565-005-85

30ml 78565-005-95

59ml 78565-005-04

59ml 78565-005-14

59ml 78565-005-24

59ml 78565-005-34

59ml 78565-005-44

59ml 78565-005-54

59ml 78565-005-64

100ml 78565-005-02

100ml 78565-005-12

227ml 78565-005-06

227ml 78565-005-16

236ml 78565-005-07

236ml 78565-005-17


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)