Your browser does not support JavaScript! SUPER SPOT REMOVER ACNE TREATMENT (SALICYLIC ACID) GEL [ORIGINS NATURAL RESOURCES INC.]
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SUPER SPOT REMOVER ACNE TREATMENT (salicylic acid) gel
[ORIGINS NATURAL RESOURCES INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

© 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

Principal Display Panel - 10 ml Carton
SUPER SPOT REMOVER ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:59427-005-011 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/FEIBusiness Operations
ELGC K.K.712808195RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59427-005), RELABEL(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(59427-005)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(59427-005), RELABEL(59427-005)

Revised: 9/2012
 
ORIGINS NATURAL RESOURCES INC.

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