K CARE OCEAN MIST: Package Insert and Label Information

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

IMAGE OF THE LABEL
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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

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