PURITY MADE SIMPLE- salicylic acid cream

purity made simple by

Drug Labeling and Warnings

purity made simple by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc., Process Technologies and Packaging Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.

INGREDIENTS AND APPEARANCE

PURITY MADE SIMPLE 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50184-1060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-1060-1	1 in 1 CARTON	04/01/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 50184-1060-2	1 in 1 CARTON	04/01/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/01/2018

Labeler - Philosophy, Inc. (948102256)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies and Packaging Inc.		809172885	manufacture(50184-1060)