purahands hand sanitizer (gel - 2 fl oz.) ndc: 78256-104-02;

purahands hand sanitizer (gel - 2 fl oz.) ndc: 78256-104-02;
SPL v1
SPL
SPL Set ID a7d50196-20b4-4f6c-e053-2a95a90a3069
Route
topical
Published
Effective Date 2020-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
trolamine carbomer homopolymer, unspecified type glycerin .alpha.-tocopherol water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-11

Purpose

Antiseptic

Description

Alcohol 70% v/v.


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Carbomer, Glycerin, Triethanolamine, Vitamin E, Water

Description

Alcohol 70% v/v.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 70% v/v.

Package Label Principal Display Panel

DISTRIBUTED BY:

PuraHands

99 Wall Street #570

New York, NY 10005

PuraHands Hand Sanitizer (2 fl. oz.) NDC: 78256-104-02

PuraHands Hand Sanitizer (8 fl. oz.) NDC: 78256-104-08

PuraHands Hand Sanitizer (16 fl. oz.) NDC: 78256-104-16


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Carbomer, Glycerin, Triethanolamine, Vitamin E, Water

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 70% v/v.

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

DISTRIBUTED BY:

PuraHands

99 Wall Street #570

New York, NY 10005

PuraHands Hand Sanitizer (2 fl. oz.) NDC: 78256-104-02

PuraHands Hand Sanitizer (8 fl. oz.) NDC: 78256-104-08

PuraHands Hand Sanitizer (16 fl. oz.) NDC: 78256-104-16


Advanced Ingredient Data


Raw Label Data

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