ANTIMICROBIAL FOAMING  FALLING RAIN- benzethonium chloride liquid 
APOLLO HEALTH AND BEAUTY CARE

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

ANTIMICROBIAL

USES

FOR 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 A POISON CONTROL CENTER IMMEDIATELY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK A DOCTOR

IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

DIRECTIONS

PUMP INTO WET HANDS.  WORK INTO A LATHER VIGOROUSLY.  RINSE THOROUGHLY.

INACTIVE INGREDIENTS

WATER, COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, POLYQUATERNIUM-7, FRAGRANCE, CAMELLIA SINENSIS, ZINGIBER OFFICINALE, HIBISCUS SABDARIFFA, CHAMOMILA RECUTITA, CITRIC ACID, ORIGANUM VULGARE LEAF EXTRACT, THYMUS VULGARE (THYME) EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, ROSEMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) ROOT EXTRACT, TETRASODIUM EDTA, GREEN 5, RED 33, YELLOW 5.

image of label

ANTIMICROBIAL FOAMING   FALLING RAIN
benzethonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-241
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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-241-12354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/22/2011
Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 7/2011
Document Id: 54677fac-cf5e-4cdd-a77c-5780a69ba972
Set id: 24adb3f5-5d16-4c29-a9dd-15832de7fb33
Version: 1
Effective Time: 20110722
 
APOLLO HEALTH AND BEAUTY CARE