Hand Sanitizer Plus Products Listing

Hand Sanitizer Plus Products Listing
SPL v1
SPL
SPL Set ID a9de7fd7-4a74-1df3-e053-2a95a90aebd4
Route
TOPICAL
Published
Effective Date 2020-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.7 L)
Inactive Ingredients
Fd&c Blue No. 1 Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Ppg-3 Benzyl Ether Myristate Anhydrous Citric Acid Water Glycerin Phenoxyethanol Ammonia

Identifiers & Packaging

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

Description

Ethyl alcohol 70% v/v

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl alcohol 70% v/v

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Section 51945-4

3.8 L NDC: 79380-011-12

Warnings

Flammable, keep away from source of heat, fire or flame.

For external use only. Do not inhale or ingest.

Directions

place enough product in your palm to thoroughly cover your hands and rub them together until dry.

children under 6 years of age should be supervised when using this product.

Active Ingredient

Ethyl alcohol 70% v/v

Other Information

do not store above 109°F (43°C).

may discolor certain surfaces or fabrics.

Inactive Ingredients

Product 011 "DRUG FACTS Fusoni Hand Sanitizer Plus.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Ammonium Hydroxide.

Product 012 "DRUG FACTS Fusoni Hand Sanitizer Plus Blue.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Blue 1, Ammonium Hydroxide.

When Using This Product

do not use in or near the eyes; if contact occurs, rinse eyes

thoroughly with water.

avoid contact with broken skin.

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Section 51945-4 (51945-4)

3.8 L NDC: 79380-011-12

Purpose

Antimicrobial

Warnings

Flammable, keep away from source of heat, fire or flame.

For external use only. Do not inhale or ingest.

Directions

place enough product in your palm to thoroughly cover your hands and rub them together until dry.

children under 6 years of age should be supervised when using this product.

Active Ingredient

Ethyl alcohol 70% v/v

Other Information (Other information)

do not store above 109°F (43°C).

may discolor certain surfaces or fabrics.

Inactive Ingredients (Inactive ingredients)

Product 011 "DRUG FACTS Fusoni Hand Sanitizer Plus.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Ammonium Hydroxide.

Product 012 "DRUG FACTS Fusoni Hand Sanitizer Plus Blue.jpg":

Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Blue 1, Ammonium Hydroxide.

When Using This Product (When using this product)

do not use in or near the eyes; if contact occurs, rinse eyes

thoroughly with water.

avoid contact with broken skin.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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