CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN - benzethonium chloride liquid 
AMERICAN SALES 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.

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DRUG FACTS

ACTIVE INGREDIENT

BENZETHONIUM CHLORIDE 0.1 PERCENT

PURPOSE

ANTIBACTERIAL

USES

FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK A DOCTOR

IF IRRITATION OR RASH DEVELOPS AND LASTS.

DIRECTIONS

PUMP ONTO DRY HANDS, WORK INTO A LATHER AND RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, POLYQUATERNIUM-7, POLYSORBATE 20, FRAGRANCE, CAMELLIA SINENSIS LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CITRIC ACID, ORIGANUM VULGARE LEAF EXTRACT, THYMUS VULGARE (THYME) FLOWER/ LEAF EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) ROOT EXTRACT, TETRASODIUM EDTA, GREEN 5 (CI 61570), RED 33 (CI 17200), YELLOW 5 (CI 19140).

IMAGE OF ANTIBACTERIAL FOAMING
CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN 
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GINGER (UNII: C5529G5JPQ)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
CHAMOMILE (UNII: FGL3685T2X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OREGANO (UNII: 0E5AT8T16U)  
THYME (UNII: CW657OBU4N)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
ROSEMARY (UNII: IJ67X351P9)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
EDETATE SODIUM (UNII: MP1J8420LU)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-241-08221 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/25/2011
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 5/2011
Document Id: 286c994c-9d23-458a-933d-5d1bf760842a
Set id: 0d8cb73e-d557-497f-ac10-614855cc7487
Version: 2
Effective Time: 20110525
 
AMERICAN SALES COMPANY