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

Active Ingredient

SALICYLIC ACID   2%

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.


Structured Label Content

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Active Ingredient (55106-9)

SALICYLIC ACID   2%

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

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.


Advanced Ingredient Data


Raw Label Data

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