CLEAR IMPROVEMENT PORE CLEARING MOISTURIZER- salicylic acid lotion

CLEAR IMPROVEMENT PORE CLEARING MOISTURIZER by

Drug Labeling and Warnings

CLEAR IMPROVEMENT PORE CLEARING MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, NORTHTEC INC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.0%

Purpose

Acne Treatment

Use

• treats acne
• clears acne blemishes
• helps prevent development of new acne blemishes

Warnings

For external use only

When using this product using other topical acne drugs at the same time or right after 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.

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

Directions

• cleanse skin thoroughly before applying
• cover the entire affected area with one application daily
• gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to every other day.
• If going outside, use a sunscreen. Allow product to dry, then follow sunscreen directions. If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

water\aqua\eau ethylhexyl palmitate ppg-14 butyl ether hamamelis virginiana (witch hazel) water dimethicone ammonium acryloyldimethyltaurate/vp copolymer peg-7 glyceryl cocoate silica steareth-21 lavandula angustifolia (lavender) oil1, citrus limon (lemon) peel oil1, mentha viridis (spearmint) leaf oil1, gaultheria procumbens (wintergreen) leaf oil1, cananga odorata (ylang ylang) flower oil1, eugenia caryophyllus (clove) bud oil1, rosmarinus officinalis (rosemary) leaf oil1, citral, geraniol, eugenol, linalool, limonene, benzyl benzoate eugenia caryophyllus (clove) flower extract charcoal powder porphyra yezoensis (algae) extract sucrose2 glycine algae extract avena sativa (oat) kernel extract caffeine glucosamine hcl sodium hyaluronate laminaria saccharina extract glycine soja (soybean) seed extract butylene glycol steareth-2 zinc pca quaternium-22 menthol alcohol disodium edta phenoxyethanol <iln45635>

1 essential oil

2 organic sucrose (brown sugar)

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ORIGINS

CLEAR
IMPROVEMENT™

Pore Clearing Moisturizer
with Bamboo Charcoal

1.7 fl. oz./oz. liq./50 mle

INGREDIENTS AND APPEARANCE

CLEAR IMPROVEMENT PORE CLEARING MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	Salicylic acid	0.01015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ethylhexyl palmitate (UNII: 2865993309)
ppg-14 butyl ether (UNII: R199TJT95T)
witch hazel (UNII: 101I4J0U34)
dimethicone (UNII: 92RU3N3Y1O)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
peg-7 glyceryl cocoate (UNII: VNX7251543)
silicon dioxide (UNII: ETJ7Z6XBU4)
steareth-21 (UNII: 53J3F32P58)
lavender oil (UNII: ZBP1YXW0H8)
lemon oil (UNII: I9GRO824LL)
spearmint oil (UNII: C3M81465G5)
methyl salicylate (UNII: LAV5U5022Y)
cananga oil (UNII: 8YOY78GNNX)
clove oil (UNII: 578389D6D0)
rosemary oil (UNII: 8LGU7VM393)
citral (UNII: T7EU0O9VPP)
geraniol (UNII: L837108USY)
eugenol (UNII: 3T8H1794QW)
linalool, (+/-)- (UNII: D81QY6I88E)
limonene, (+)- (UNII: GFD7C86Q1W)
benzyl benzoate (UNII: N863NB338G)
clove (UNII: K48IKT5321)
activated charcoal (UNII: 2P3VWU3H10)
phymatolithon calcareum (UNII: 6J1M3WA0ZK)
sucrose (UNII: C151H8M554)
glycine (UNII: TE7660XO1C)
oat (UNII: Z6J799EAJK)
caffeine (UNII: 3G6A5W338E)
glucosamine hydrochloride (UNII: 750W5330FY)
hyaluronate sodium (UNII: YSE9PPT4TH)
saccharina latissima (UNII: 68CMP2MB55)
soybean (UNII: L7HT8F1ZOD)
butylene glycol (UNII: 3XUS85K0RA)
steareth-2 (UNII: V56DFE46J5)
zinc pidolate (UNII: C32PQ86DH4)
quaternium-22 (UNII: MXO138JCBP)
menthol, unspecified form (UNII: L7T10EIP3A)
alcohol (UNII: 3K9958V90M)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-015-01	1 in 1 CARTON	09/23/2019
1		50 mL in 1 JAR; 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	09/23/2019

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-015) , REPACK(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-015) , REPACK(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-015) , REPACK(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-015)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-015)