Label: H2OCEAN NOTHING- benzalkonium cl, lidocaine hcl liquid
- NDC Code(s): 70411-104-50
- Packager: H2Ocean, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredients
- Questions?
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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 34997Distributed in Europe By
H2Ocean Europe SARL, LTD.
Waterford
Ireland, X91 EH5NUSA. / EU. +1-772-219-8183
info@h2ocean.com
www.h2ocean.com
Made in USA - Packaging
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INGREDIENTS AND APPEARANCE
H2OCEAN NOTHING
benzalkonium cl, lidocaine hcl liquidProduct 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)