Ms

Ms
SPL v2
SPL
SPL Set ID bef71cb5-7bc6-4654-ae75-bc724c6ee80c
Route
TOPICAL
Published
Effective Date 2020-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Propylene Glycol Disodium Cocoamphodiacetate Bronopol Methylchloroisothiazolinone Methylisothiazolinone Polyoxyl 40 Hydrogenated Castor Oil .alpha.-tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-13

Description

Ethyl alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 75%

Uses

• hand wipes to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5

kills up to  99.9% of bacteria*

THICK & DURABLE

DEEP, GENTLE CLEAN QUICK & EASY

UNSCENTED - HYPOALLERGENIC

75% plant based alcohol

enriched with aloe vera

vitamin E

NO FRAGRANCE

NO PARABEN

NO SULPHATES

(*) Tested under lab conditions.

Distributed by: The Germ Safe Company, Inc.

701 Brickell Key Boulevard, #1903 Miami, FL -33131

MADE IN VIETNAM

Manufacturing date: Printed on the label

Expiration date: 36 months from manufacturing date

NOT TESTED ON ANIMALS

ISO

GMP

Section 51727-6

Inactive ingredients  water, glycerin, propylene glycol, disodium cocoamphodiacetate, 2-bromo-2-nitropropane-1,3-diol, methychloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil, vitamin E, aloe vera (Aloe barbadensis) extract.

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

• as a diaper wipe

When using this product 

• do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions

• open resealable sticker label. Pull wipes as needed. Close the resealable sticker label firmly to keep wipes moist, prevent from drying out and maintain the quality

• wipe hands thoroughly with product and allow to dry

• dispose the wipe after use

• supervise children under 6 years of age when using this product to avoid swallowing

• do not flush down the toilet

Questions?

+1-909-442-0096

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

purpose

Antiseptic

drug Facts

Active Ingredient

Ethyl alcohol 75%

Other Information

• store between 15-30˚C (59-86˚F)

• avoid freezing and excessive heat above 40˚C (104˚F)

Keep Out of Reach of Children.

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


Structured Label Content

Uses

• hand wipes to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5 (42229-5)

kills up to  99.9% of bacteria*

THICK & DURABLE

DEEP, GENTLE CLEAN QUICK & EASY

UNSCENTED - HYPOALLERGENIC

75% plant based alcohol

enriched with aloe vera

vitamin E

NO FRAGRANCE

NO PARABEN

NO SULPHATES

(*) Tested under lab conditions.

Distributed by: The Germ Safe Company, Inc.

701 Brickell Key Boulevard, #1903 Miami, FL -33131

MADE IN VIETNAM

Manufacturing date: Printed on the label

Expiration date: 36 months from manufacturing date

NOT TESTED ON ANIMALS

ISO

GMP

Section 51727-6 (51727-6)

Inactive ingredients  water, glycerin, propylene glycol, disodium cocoamphodiacetate, 2-bromo-2-nitropropane-1,3-diol, methychloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil, vitamin E, aloe vera (Aloe barbadensis) extract.

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

• as a diaper wipe

When using this product 

• do not get into eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions

• open resealable sticker label. Pull wipes as needed. Close the resealable sticker label firmly to keep wipes moist, prevent from drying out and maintain the quality

• wipe hands thoroughly with product and allow to dry

• dispose the wipe after use

• supervise children under 6 years of age when using this product to avoid swallowing

• do not flush down the toilet

Questions?

+1-909-442-0096

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

purpose (Purpose)

Antiseptic

drug Facts (Drug Facts)

Active Ingredient (Active ingredient)

Ethyl alcohol 75%

Other Information (Other information)

• store between 15-30˚C (59-86˚F)

• avoid freezing and excessive heat above 40˚C (104˚F)

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

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


Advanced Ingredient Data


Raw Label Data

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