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SUPER SPOT REMOVER ACNE TREATMENT

Dosage form: gel
Ingredients: SALICYLIC ACID 2mL in 100mL
Labeler: ORIGINS NATURAL RESOURCES INC.
NDC Code: 59427-005

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.

SUPER SPOT REMOVER™ ACNE TREATMENT

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 oil, 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>


essential oil

© 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

SUPER SPOT REMOVER ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
witch hazel 
clove oil 
eugenol 
cucumber 
apple 
scutellaria baicalensis root 
saccharina latissima 
glycerin 
caffeine 
butylene glycol 
.alpha.-tocopherol acetate 
magnesium ascorbyl phosphate 
sodium hydroxide 
phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:59427-005-011 CONTAINER in 1 CARTON
110 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D04/01/2012
Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-005), RELABEL(59427-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(59427-005), RELABEL(59427-005)

Revised: 09/2012
 
ORIGINS NATURAL RESOURCES INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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