Otc Drug Facts

Otc Drug Facts
SPL v1
SPL
SPL Set ID 622549ec-c7af-45fb-bd1b-57326a6a0e94
Route
TOPICAL
Published
Effective Date 2011-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.184 mL)
Inactive Ingredients
Water Ethylhexyl Palmitate Cetyl Alcohol Butylene Glycol Glyceryl Monostearate Dimethicone Cetostearyl Alcohol Alpha-tocopherol Acetate Lavender Oil Peg-100 Stearate Polyoxyl 20 Cetostearyl Ether Xanthan Gum C13-14 Isoparaffin Laureth-7 Trolamine Edetate Sodium Propylene Glycol Methylparaben Propylparaben Diazolidinyl Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-28

Description

SALICYLIC ACID   2%


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.





CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR



Dosage and Administration

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.



COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY



BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR

Description

SALICYLIC ACID   2%

Section 50565-1

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

Section 50569-3

STOP USE AND ASK A DOCTOR IF EXCESSIVE SKIN IRRITATIONS DEVELOPS OR INCREASES

Section 51727-6

water

ethylhexyl palmitate

cetyl alcohol

butylene glycol

glyceryl stearate 

allyl methacrylates crosspolymer

ppg-12/smdi copolymer

dimethicone

cetearyl alcohol

tocopheryl acetate

lavandula angustifolia (lavender) oil

PEG-100 stearate

ceteareth-20

xanthan gum

polyacrylamide

c13-14 isoparaffin

laureth-7

triethanolamine

tetrasodium edta

propylene glycol

methylparaben

propylparaben

diazolidinyl urea



Section 51945-4

Section 53414-9

IF PREGNANT OR BREAST FEEDING ASK A HEALTH PROFESSIONAL BEFORE USE

Section 55105-1

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.



PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.

Section 55106-9

SALICYLIC ACID   2%


Structured Label Content

Indications and Usage (34067-9)

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.





CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.

COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY

BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR



Dosage and Administration (34068-7)

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING.



COVER THE ENTIRE EFFECTED AREA 1 TO 3 TIMES DAILY



BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR STATE WITH 1 APPLICATION DAILY THEN GRADUALLY INCREASE TO 2 OR 3 IF NEEDED OR AS DIRECTED BY YOUR DOCTOR

Warnings and Precautions (34071-1)

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 50569-3 (50569-3)

STOP USE AND ASK A DOCTOR IF EXCESSIVE SKIN IRRITATIONS DEVELOPS OR INCREASES

Section 51727-6 (51727-6)

water

ethylhexyl palmitate

cetyl alcohol

butylene glycol

glyceryl stearate 

allyl methacrylates crosspolymer

ppg-12/smdi copolymer

dimethicone

cetearyl alcohol

tocopheryl acetate

lavandula angustifolia (lavender) oil

PEG-100 stearate

ceteareth-20

xanthan gum

polyacrylamide

c13-14 isoparaffin

laureth-7

triethanolamine

tetrasodium edta

propylene glycol

methylparaben

propylparaben

diazolidinyl urea



Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

IF PREGNANT OR BREAST FEEDING ASK A HEALTH PROFESSIONAL BEFORE USE

Section 55105-1 (55105-1)

HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.



PENETRATES PORES TO CLEAR MOST ACNE BLEMISHES.

Section 55106-9 (55106-9)

SALICYLIC ACID   2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)