AURORA ANTIBACTERIAL APPLE SUMMER BERRY- triclosan 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

TRICLOSAN 0.46%

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 EYES THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS MORE THAN 7 DAYS

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

APPLY TO DRY HANDS, WORK INTO A RICH FOAMY LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM LAURETH SULFATE, POLYSORBATE 20, FRAGRANCE (PARFUM), COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-7, PEG-8, PEG-7 GLYCERYL COCOATE, TETRASODIUM EDTA, BHT, BENZOPHENONE-4, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200), YELLOW 5 (CI 19140)

LABEL COPY

IMAGE OF THE LABEL

AURORA  ANTIBACTERIAL APPLE SUMMER BERRY
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN4.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SULISOBENZONE (UNII: 1W6L629B4K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-105-08237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/13/2015
Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(63148-105)

Revised: 1/2015
Document Id: eb0ccb12-abbe-4881-8543-a2e6ad8524d4
Set id: 15733797-2308-4ecc-a6df-b58cd240cd7d
Version: 1
Effective Time: 20150114
 
APOLLO HEALTH AND BEAUTY CARE