SUPER SPOT REMOVER ACNE TREATMENT- salicylic acid gel

SUPER SPOT REMOVER ACNE TREATMENT by

Drug Labeling and Warnings

SUPER SPOT REMOVER ACNE TREATMENT 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 LLC, PADC 1, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.50%

Purpose

Acne treatment

Uses

• For the treatment of acne

Warnings

For external use only.

Avoid eye area.

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 swallowed, call a doctor or contact a Poison Control Center right away.

Directions

• Cleanse skin.
• Apply a thin layer 1 to 3 times daily or as needed.
• If dryness or peeling occurs, reduce application to every other day.

Inactive ingredients

water\aqua\eau alcohol denat. acrylates/c10-30 alkyl acrylate crosspolymer hamamelis virginiana (witch hazel) eugenia caryophyllus (clove) bud oil1, origanum heracleoticum flower oil1, eugenol, limonene cucumis sativus (cucumber) fruit extract pyrus malus (apple) fruit extract scutellaria baicalensis root extract algae extract poria cocos sclerotium extract laminaria saccharina extract lactobacillus ferment glycerin caffeine butylene glycol tocopheryl acetate magnesium ascorbyl phosphate sodium hydroxide phenoxyethanol <iln37864>

1 essential oil

SPL UNCLASSIFIED SECTION

© Origins Nat. Res., Dist.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 10 ml Carton

ORIGINS

Super Spot
Remover™

Acne treatment gel
salicylic acid

.3 fl. oz./oz. liq./
10 ml e

INGREDIENTS AND APPEARANCE

SUPER SPOT REMOVER ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-005
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 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
witch hazel (UNII: 101I4J0U34)
clove oil (UNII: 578389D6D0)
eugenol (UNII: 3T8H1794QW)
cucumber (UNII: YY7C30VXJT)
apple (UNII: B423VGH5S9)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
saccharina latissima (UNII: 68CMP2MB55)
glycerin (UNII: PDC6A3C0OX)
caffeine (UNII: 3G6A5W338E)
butylene glycol (UNII: 3XUS85K0RA)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
sodium hydroxide (UNII: 55X04QC32I)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-005-01	1 in 1 CARTON
1		10 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	04/01/2012

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59427-005) , REPACK(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59427-005) , RELABEL(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59427-005) , RELABEL(59427-005) , REPACK(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59427-005)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(59427-005) , RELABEL(59427-005)