SPL v2
SPL
SPL Set ID c73953ab-09fa-4116-82c8-8f9d6f9d679e
Route
TOPICAL
Published
Effective Date 2011-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Talc Dimethicone Starch, Corn Zinc Stearate Sucrose Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-10-01

Description

ACTIVE INGREDIENT :    SALICYLIC ACID 0.5%


Medication Information

Warnings and Precautions

WARNINGS: FOR EXTERNAL USE ONLY. 

Indications and Usage

INDICATIONS: FOR THE TREATMENT OF ACNE

Dosage and Administration


DIRECTIONS

  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING
  • COVER THE ENTIRE AFFECTED AREA WITH ONE APPLICATION
  • GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.
Description

ACTIVE INGREDIENT :    SALICYLIC ACID 0.5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50567-7


WHEN USING THIS PRODUCT: 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.
Section 51727-6

INACTIVE INGREDIENTS:

talc [] dimethicone [] silica [] zea mays (corn) starch [] polymethyl methacrylate [] zinc stearate [] cetearyl ethylhexanoate [] trimethylsiloxysilicate [] sucrose [] ethylhexylglycerin [] nylon-12 [] octyldodecyl lactate [] lauroyl lysine [] pca [] lauryl alcohol [] bht [] chlorphenesin [] potassium sorbate [] tetrasodium edta []  [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891) [] yellow 5 lake (ci 19140) [] chromium oxide greens (ci 77288) [] chromium hydroxide green (ci 77289) [] carmine (ci 75470) [] bismuth oxychloride (ci 77163) [] blue 1 lake (ci 42090) [] yellow 6 lake (ci 15985) [] red 7 lake (ci 15850) [] red 6 (ci 15850) [] red 30 (ci 73360) [] ferric ferrocyanide (ci 77510

Section 51945-4


PRINCIPLE DISPLAY PANEL:

 





CLINIQUE



CLARIFYING POWDER MAKEUP



NET WT. .38 OZ/11 g





clinique labs dist



new york, ny 10022











Section 55105-1

PURPOSE:  ACNE TREATMENT

USE:  FOR THE TREATMENT OF ACNE

CLEARS UP ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

Section 55106-9


ACTIVE INGREDIENT:    SALICYLIC ACID 0.5%


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS: FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)


DIRECTIONS

  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING
  • COVER THE ENTIRE AFFECTED AREA WITH ONE APPLICATION
  • GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.
Warnings and Precautions (34071-1)

WARNINGS: FOR EXTERNAL USE ONLY. 

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50567-7 (50567-7)


WHEN USING THIS PRODUCT: 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.
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

talc [] dimethicone [] silica [] zea mays (corn) starch [] polymethyl methacrylate [] zinc stearate [] cetearyl ethylhexanoate [] trimethylsiloxysilicate [] sucrose [] ethylhexylglycerin [] nylon-12 [] octyldodecyl lactate [] lauroyl lysine [] pca [] lauryl alcohol [] bht [] chlorphenesin [] potassium sorbate [] tetrasodium edta []  [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891) [] yellow 5 lake (ci 19140) [] chromium oxide greens (ci 77288) [] chromium hydroxide green (ci 77289) [] carmine (ci 75470) [] bismuth oxychloride (ci 77163) [] blue 1 lake (ci 42090) [] yellow 6 lake (ci 15985) [] red 7 lake (ci 15850) [] red 6 (ci 15850) [] red 30 (ci 73360) [] ferric ferrocyanide (ci 77510

Section 51945-4 (51945-4)


PRINCIPLE DISPLAY PANEL:

 





CLINIQUE



CLARIFYING POWDER MAKEUP



NET WT. .38 OZ/11 g





clinique labs dist



new york, ny 10022











Section 55105-1 (55105-1)

PURPOSE:  ACNE TREATMENT

USE:  FOR THE TREATMENT OF ACNE

CLEARS UP ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

Section 55106-9 (55106-9)


ACTIVE INGREDIENT:    SALICYLIC ACID 0.5%


Advanced Ingredient Data


Raw Label Data

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