Drug Labeling and Warnings

Drug Details

k">

PURITY MADE SIMPLE- salicylic acid cream 
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.

----------

Drug Facts

Active Ingredient

Salicylic Acid (0.5%)

Purpose

Acne Treatment

Indications

For the treatment of acne

Warnings

For external use only.

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor.

Directions

  • gently massage onto clean, dry skin focusing on your t-zone and oily areas.
  • leave on skin for 5–10 minutes, or until the clay is completely dry. rinse with warm water.
  • for deeper exfoliation, increase the massage intensity when applying, and while removing with water, perform a second massage.
  • we recommend using two times per week.
  • this product may cause eye irritation. avoid contact with eyes. if contact occurs, flush with plenty of water. if irritation persists, consult a physician.

Inactive Ingredients

water, kaolin, diatomaceous earth, propanediol, bentonite, decyl glucoside, alcohol denat., lauryl glucoside, propylene glycol, polysilicone-11, pvp, xanthan gum, sodium pca, sodium citrate, citric acid, fragrance, chlorphenesin, disodium edta, laureth-12, phenoxyethanol, vanillyl butyl ether, ethylhexylglycerin, titanium dioxide (ci 77891).

Questions or Comments?

Call toll-free 1-800-568-3151 from 9 a.m. - 8 p.m. ET (Monday – Friday)

Principal Display Panel - 75 mL Carton Label

purity
made simple
pore extract

philosophy: no one
is perfect, but we can
all be pure. purity is
intention. purity is
perspective. purity
is principle. reserve
judgment, and treat
others the way you
want to be treated.

exfoliating clay mask
salicylic acid acne treatment

75 ml/2.5 fl. oz.

Figure

Principal Display Panel - 75 mL Tube Label

purity
made simple
pore extract

philosophy: no one
is perfect, but we can
all be pure. purity is
intention. purity is
perspective. purity
is principle. reserve
judgment, and treat
others the way you
want to be treated.

exfoliating clay mask
salicylic acid acne treatment

75 ml/2.5 fl. oz.

Figure
PURITY MADE SIMPLE 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50184-1060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
PROPANEDIOL (UNII: 5965N8W85T)  
BENTONITE (UNII: A3N5ZCN45C)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ALCOHOL (UNII: 3K9958V90M)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-12 (UNII: OAH19558U1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50184-1060-11 in 1 CARTON04/01/2018
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 50184-1060-21 in 1 CARTON04/01/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/01/2018
Labeler - Philosophy, Inc. (948102256)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies and Packaging Inc.809172885manufacture(50184-1060)

Revised: 2/2019
 
Philosophy, Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.