SPOT REMOVER ACNE TREATMENT PADS- salicylic acid liquid

SPOT REMOVER ACNE TREATMENT PADS by

Drug Labeling and Warnings

SPOT REMOVER ACNE TREATMENT PADS by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.5%

Purpose

Acne treatment

Uses

• Treats acne, blackheads and whiteheads
• Penetrates pores to control acne blemishes
• Helps prevent the development of new acne blemishes

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

• Use AM and PM after cleansing. Sweep pad over affected areas, avoiding eye area.
• If dryness or peeling occurs, reduce application to every other day.

Inactive ingredients

water\aqua\eau alcohol denat. peg-60 almond glycerides betaine eugenia caryophyllus (clove) bud oil1, origanum heracleoticum flower oil1, eugenol boswellia serrata extract serenoa serrulata (saw palmetto) fruit extract phyllanthus emblica fruit extract caffeine sodium hydroxide <iln37564>

1 essential oil

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Carton

ORIGINS

Spot Remover™

Acne treatment pads
salicylic acid

60 Pads

INGREDIENTS AND APPEARANCE

SPOT REMOVER ACNE TREATMENT PADS 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.009506 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
peg-60 almond glycerides (UNII: 4Y0E651N0F)
betaine (UNII: 3SCV180C9W)
clove oil (UNII: 578389D6D0)
eugenol (UNII: 3T8H1794QW)
indian frankincense (UNII: 4PW41QCO2M)
saw palmetto (UNII: J7WWH9M8QS)
phyllanthus emblica fruit (UNII: YLX4CW2576)
caffeine (UNII: 3G6A5W338E)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-110-01	60 in 1 JAR	04/01/2011
1		1 mL in 1 APPLICATOR; 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	04/01/2011

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(59427-110) , REPACK(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(59427-110) , REPACK(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(59427-110) , REPACK(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59427-110)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(59427-110)