H2

H2
SPL v1
SPL
SPL Set ID 77896ac3-960c-41ac-8b40-053f24526fe3
Route
TOPICAL
Published
Effective Date 2024-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Aloe Vera Leaf Edetate Disodium Poloxamer 407 Sea Salt Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

Benzalkonium Cl 0.13% Lidocaine HCl 4%

Purpose

First aid antiseptic Pain reliever


Medication Information

Purpose

First aid antiseptic

Pain reliever

Description

Benzalkonium Cl 0.13% Lidocaine HCl 4%

Uses

• first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns

• first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy

Section 42229-5

First In First Aid

ACTS IN 2 MINUTES

LASTING UP TO 20 MINUTES

MAX STRENGTH

Antiseptic and Anesthetic

RECYCLABLE

Distributed By

H2Ocean, LLC.


Stuart, FL,

USA 34997

Distributed in Europe By

H2Ocean Europe SARL, LTD.

Waterford

Ireland, X91 EH5N

USA. / EU. +1-772-219-8183

[email protected]

www.h2ocean.com

Made in USA

Section 50565-1

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

Warnings

For external use only.

Do not use • in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Packaging

Directions

• clean the affected area

• adults and children 2 years of age and older: apply a small amount of this product on the area 1 to 3 times daily 

• may be covered with a sterile bandage

• if bandaged, let dry first

• children under 2 years of age: do not use, consult a physician

Drug Facts

Questions?

+1-772-219-8183

Other Information

• this package is child-resistant

• store at room temperature

Active Ingredients

Benzalkonium Cl 0.13%

Lidocaine HCl 4%

Inactive Ingredients

Aloe (Aloe barbadensis) Leaf Juice, Disodium EDTA, Poloxamer 407, Sea Salt, Water


Structured Label Content

Uses

• first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns

• first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy

Section 42229-5 (42229-5)

First In First Aid

ACTS IN 2 MINUTES

LASTING UP TO 20 MINUTES

MAX STRENGTH

Antiseptic and Anesthetic

RECYCLABLE

Distributed By

H2Ocean, LLC.


Stuart, FL,

USA 34997

Distributed in Europe By

H2Ocean Europe SARL, LTD.

Waterford

Ireland, X91 EH5N

USA. / EU. +1-772-219-8183

[email protected]

www.h2ocean.com

Made in USA

Section 50565-1 (50565-1)

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

Purpose

First aid antiseptic

Pain reliever

Warnings

For external use only.

Do not use • in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Packaging

Directions

• clean the affected area

• adults and children 2 years of age and older: apply a small amount of this product on the area 1 to 3 times daily 

• may be covered with a sterile bandage

• if bandaged, let dry first

• children under 2 years of age: do not use, consult a physician

Drug Facts

Questions?

+1-772-219-8183

Other Information (Other information)

• this package is child-resistant

• store at room temperature

Active Ingredients (Active ingredients)

Benzalkonium Cl 0.13%

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

Aloe (Aloe barbadensis) Leaf Juice, Disodium EDTA, Poloxamer 407, Sea Salt, Water


Advanced Ingredient Data


Raw Label Data

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