PROVEN ACNE CLEANSER- salicylic acid cream

Proven Acne Cleanser by

Drug Labeling and Warnings

Proven Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Proven Skincare, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

Use For the treatment of acne.

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product - skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

STOP USE

Stop use and ask doctor if irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Gently massage 2-4 pumps of cleanser over damp face and neck. Rinse with warm water and pat dry.

INACTIVE INGREDIENT

Azelaic acid

Camellia Sinensis Leaf Extract

Caprylyl Glycol

Dissodium EDTA

DMAE Bitartrate

Ethanol

Ethylhexylglycerin

Fragrance

Glycerin

Lactic Acid

Lactobacillus Bulgaricus Ferment Filtrate

Leuconostoc/Radish Root Ferment Filtrate

Panax Ginseng Root Extract

Papain

Pentylene Glycol

Phenoxyethanol

Polyacrylate-13

Polyisobutene

Polysorbate 20

Propanediol

Punica Granatum Extract

Saccharomyces Ferment

Salix Alba (Willow) Bark Extract

Sodium Chloride

Sodium Hyaluronate

Sodium PCA

Sodium Hydroxide

Sodium Lauroyl Isethionate

Sorbitan Isostearate

Tasmannia Lanceolata Fruit/Leaf Extract

Water

Witch Hazel Distillate

Xanthum Gum

QUESTIONS

Go to www.provenskincare.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVEN ACNE CLEANSER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73572-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AZELAIC ACID (UNII: F2VW3D43YT)
DEANOL BITARTRATE (UNII: D240J05W14)
LACTOBACILLUS DELBRUECKII BULGARICUS (UNII: HU1W4L947H)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WITCH HAZEL (UNII: 101I4J0U34)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE 13576 (UNII: 5EM498GW35)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
SODIUM PCA (UNII: 469OTG57A2)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PAPAIN (UNII: A236A06Y32)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SALIX ALBA BARK (UNII: 205MXS71H7)
SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73572-011-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	01/01/2024

Labeler - Proven Skincare (117370905)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(73572-011)