H2OCEAN NOTHING- benzalkonium cl, lidocaine hcl liquid

H2OCEAN NOTHING by

Drug Labeling and Warnings

H2OCEAN NOTHING by is a Otc medication manufactured, distributed, or labeled by H2Ocean, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium Cl 0.13%
Lidocaine HCl 4%

Purpose

First aid antiseptic
Pain reliever

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

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

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

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

Other information

this package is child-resistant
store at room temperature

Inactive ingredients

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

Questions?

+1-772-219-8183

SPL UNCLASSIFIED SECTION

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

info@h2ocean.com
www.h2ocean.com
Made in USA

Packaging

INGREDIENTS AND APPEARANCE

H2OCEAN NOTHING 
benzalkonium cl, lidocaine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70411-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SEA SALT (UNII: 87GE52P74G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70411-104-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/15/2024

Labeler - H2Ocean, LLC (136298069)