HOPE IN A BOTTLE - salicylic acid lotion 
Philosophy, Inc.

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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OTC DRUG FACTS

SALICYLIC ACID   2%

water

ethylhexyl palmitate

cetyl alcohol

butylene glycol
glyceryl stearate 
allyl methacrylates crosspolymer
ppg-12/smdi copolymer
dimethicone
cetearyl alcohol
tocopheryl acetate
lavandula angustifolia (lavender) oil
PEG-100 stearate
ceteareth-20
xanthan gum
polyacrylamide
c13-14 isoparaffin
laureth-7
triethanolamine
tetrasodium edta
propylene glycol
methylparaben
propylparaben
diazolidinyl urea

STOP USE AND ASK A DOCTOR IF EXCESSIVE SKIN IRRITATIONS DEVELOPS OR INCREASES

KEEP OUT OF REACH OF CHILDREN - IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

IF PREGNANT OR BREAST FEEDING ASK A HEALTH PROFESSIONAL BEFORE USE

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.



CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR


FOR EXTERNAL USE ONLY

MM1

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR

HOPE IN A BOTTLE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-2900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.184 mL  in 59.2 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50184-2900-159.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/28/2011
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Philosophy Inc for BioTech Research Labs948102256manufacture

Revised: 9/2011
Document Id: 71718b49-ed10-4144-a696-74646ef93f7e
Set id: 622549ec-c7af-45fb-bd1b-57326a6a0e94
Version: 1
Effective Time: 20110928
 
Philosophy, Inc.