OTC Medication Information: K CARE OCEAN MIST

K CARE OCEAN MIST- benzalkonium chloride liquid
THE KROGER COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSE

ANTIBACTERIAL

USES

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS AND LASTS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222

DIRECTIONS

SQUEEZE BODY WASH ONTO WET WASHCLOTH OR POUF, WORK INTO LATHER AND USE ALL OVER BODY. RINSE CLEAN

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, GLYCERIN, CITRIC ACID, POLOXAMER 124, FRAGRANCE (PARFUM), TETRASODIUM EDTA, POLYQUATERNIUM-7, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), EXT. VIOLET 2 (CI 60730)

LABEL COPY

K CARE OCEAN MIST benzalkonium chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-802 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER COCAMIDOPROPYL BETAINE DECYL GLUCOSIDE HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) GLYCERIN CITRIC ACID MONOHYDRATE POLOXAMER 124 EDETATE SODIUM POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) SODIUM CITRATE ALOE VERA LEAF METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C BLUE NO. 1 D&C VIOLET NO. 2

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:30142-802-18 532 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/10/2014

Labeler — THE KROGER COMPANY (006999528)

Registrant — APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture (30142-802)

Revised: 04/2014 THE KROGER COMPANY