ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM- ethyl alcohol liquid 
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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

ETHYL ALCOHOL 62%

PURPOSE

ANTISEPTIC

USES

TO HELP REDUCE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR 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

DIRECTIONS

APPLY SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

OTHER INFORMATION

STORE AT A TEMPERATURE BELOW 110°F (43°C)

QUESTIONS/COMMENTS?

1-866-695-3030

INACTIVE INGREDIENTS

WATER (AQUA), PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, AMINOMETHYL PROPANOL, CARBOMER, TOCOPHERYL ACETATE, FRAGRANCE (PARFUM), VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF JUICE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, RETINYL PALMITATE, IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), RED 33 (CI 17200)

LABEL COPY

IMAGE OF THE LABEL

ORCHID  ANTIBACTERIAL VANILLA AND APPLE BLOSSOM
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 934 (UNII: Z135WT9208)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VANILLA (UNII: Q74T35078H)  
APPLE (UNII: B423VGH5S9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-165-0259 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/17/2014
Labeler - H E B (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(37808-165)

Revised: 11/2014
Document Id: 24273bb8-9f20-4002-8094-a5640daa0650
Set id: 0bccb2d6-e701-4982-9a66-357eb42758af
Version: 1
Effective Time: 20141118
 
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