Label: CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES- salicylic acid gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 62499-392-04, 62499-392-06, 62499-392-11, 62499-392-12 - Packager: Laboratoire Dr. Renaud
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 29, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Salicylic Acid 2% w/w.
INACTIVE INGREDIENTS
WATER/EAU • ETHOXYDIGLYCOL • GLYCOLIC ACID • METHYL GLUCETH 20 • SODIUM CITRATE • GLYCERIN •
PEG-40 HYDROGENATED CASTOR OIL • SODIUM HYDROXIDE • AMYLOPECTIN • DEXTRIN • LACTIC ACID* • XANTHAN GUM •
BUTYLENE GLYCOL • ARGININE* • CELLULOSE GUM • PEG-60 ALMOND GLYCERIDES • CAPRYLYL GLYCOL • ALLANTOIN •
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL • ALMOND (PRUNUS AMYGDALUS DULCIS) OIL • ROSEMARY (ROSMARINUS
OFFICINALIS) OIL • SAGE (SALVIA OFFICINALIS) OIL SPANISH • LAVANDIN (LAVANDULA LATIFOLIA) OIL •
COLEUS FORSKOHLII OIL • GALANGAL (KAEMPFERIA GALANGA) EXTRACT • CHAMOMILE (ANTHEMIS NOBILIS) OIL •
CARBOMER • NORDIHYDROGUAIARETIC ACID • OLEANOLIC ACID • ETHYLHEXYL GLYCERIN • PHENOXYETHANOL
For the treatment of acne.Reduces the number of acne pimples,blackheads and whiteheads and allows skin to heal.
DIRECTIONS
Morning and evening, first
cleanse the skin thoroughly with CLEAR UP
Cleansing Gel. Then apply a thin layer
of CLEAR UP Control Solution Anti-Blemishes
to the entire face and other affected areas
one to three times daily, or as directed by a
doctor. Massage in with light effleurages.
Then apply CLEAR UP Anti-Shine Moisturizer
SPF 15. Because excessive drying of the skin
may occur, start with one application daily,
then gradually increase to two or three times
daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs,
reduce application to once a day
or every other day.
WARNINGS
For external use only. Using
other topical acne medications at the same
time or immediately following 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.
Avoid direct contact with the eyes. If product
gets into the eyes, rinse liberally with water.
Discontinue use if skin irritation develops
or increases. If irritation persists, consult a
doctor. This product contains alpha-hydroxyacids
(AHA) which may increase sensitivity
to the sun and lead to skin burn. Reduce sun
exposure and use a sunblock during the use
of this product and the week following its use.
- PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
-
INGREDIENTS AND APPEARANCE
CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62499-392 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 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCOLIC ACID (UNII: 0WT12SX38S) METHYL GLUCETH-20 (UNII: J3QD0LD11P) SODIUM CITRATE (UNII: 1Q73Q2JULR) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) SODIUM HYDROXIDE (UNII: 55X04QC32I) AMYLOPECTIN (UNII: 4XO4QFV777) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) LACTIC ACID (UNII: 33X04XA5AT) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARGININE (UNII: 94ZLA3W45F) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALLANTOIN (UNII: 344S277G0Z) ORANGE OIL (UNII: AKN3KSD11B) ALMOND OIL (UNII: 66YXD4DKO9) ROSEMARY OIL (UNII: 8LGU7VM393) SAGE OIL (UNII: U27K0H1H2O) LAVANDIN OIL (UNII: 9RES347CKG) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) Product Characteristics Color blue (DRAK BLEU) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62499-392-11 1 in 1 CARTON 1 NDC:62499-392-04 50 g in 1 TUBE 2 NDC:62499-392-12 1 in 1 KIT 2 NDC:62499-392-06 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 06/29/2010 Labeler - Laboratoire Dr. Renaud (202501565) Registrant - Laboratoire Dr. Renaud (202501565) Establishment Name Address ID/FEI Business Operations Laboratoire Dr. Renaud 202501565 manufacture