SPOT REMOVER ACNE TREATMENT PADS- salicylic acid liquid
ORIGINS NATURAL RESOURCES INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPOT REMOVER™ ACNE TREATMENT PADS

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

Principal Display Panel - 60 Pad Jar Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	04/01/2011	11/10/2020

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

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

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

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

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

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

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

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

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

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

Revised: 12/2018

Document Id: c8d93a9b-c550-4897-aff1-d7436ef15e33

Set id: 2a82820c-6a5a-4aa0-86bb-ba9fce14c317

Version: 3

Effective Time: 20181217

ORIGINS NATURAL RESOURCES INC.