CLEAR UP Control Solution Anti-Blemiches: Package Insert and Label Information

CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES — salicylic acid gel
Laboratoire Dr. Renaud

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.

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.

image of tube 50ml lable

image of tube 50ml lable
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image of tube 15 ml lable

image of tube 15 ml lable
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image of carton 50ml label

image of carton 50ml lable
(click image for full-size original)

image of tube 50ml lableimage of tube 15 ml lableimage of carton 50ml lable Keep out of reach of children.

CLEAR UP CONTROL SOLUTION ANTI-BLEMICHES salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62499-392
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCOLIC ACID
METHYL GLUCETH-20
SODIUM CITRATE
GLYCERIN
HYDROGENATED CASTOR OIL
SODIUM HYDROXIDE
AMYLOPECTIN
OLEANOLIC ACID
LACTIC ACID
PHENOXYETHANOL
XANTHAN GUM
BUTYLENE GLYCOL
ARGININE
CARBOXYMETHYLCELLULOSE SODIUM
CAPRYLYL GLYCOL
ALLANTOIN
ORANGE OIL
ALMOND OIL
ROSEMARY OIL
SAGE OIL
LAVANDIN OIL
ETHYLHEXYLGLYCERIN
CHAMOMILE FLOWER OIL
Product Characteristics
Color blue (DRAK BLEU) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62499-392-11 1 TUBE (TUBE) in 1 CARTON contains a TUBE (62499-392-04)
1 NDC:62499-392-04 50 g in 1 TUBE This package is contained within the CARTON (62499-392-11)
2 NDC:62499-392-12 1 TUBE (TUBE) in 1 KIT contains a TUBE (62499-392-06)
2 NDC:62499-392-06 15 g in 1 TUBE This package is contained within the KIT (62499-392-12)
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 Operations
Laboratoire Dr. Renaud 202501565 manufacture

Revised: 06/2010 Laboratoire Dr. Renaud

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