DR. KARRS ACNE-STATIN- salicylic acid cream

DR. KARRS ACNE-STATIN by

Drug Labeling and Warnings

DR. KARRS ACNE-STATIN by is a Otc medication manufactured, distributed, or labeled by COLONIAL DAMES CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SALICYLIC ACID 0.5%

PURPOSE

ACNE TREATMENT

USES

• FOR THE TREATMENT OF ACNE.

WARNINGS

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNEMEDICATIONS AT THE SAME TIME OR IMMEDITELY 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.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

WHEN USING

AVOID USE AROUND THE EYES. IF CONTACT OCCURS, IMMEDIATELY FLUSH WITH WATER.

DIRECTIONS FOR USE:

DURING THE DAY: CLEANSE THE SKIN THOROUGHLY WITH ACNE-STATIN CLEANSER/MOISTURIZER LOTION (CML), INSTEAD OF SOAP. THEN RINSE WITH WATER. PAT DRY. COVER THE ENTIRE AFFECTED ARE WITHA THIN LAYER OF ACNE-STATIN ACNE TREATMENT CREAM (ACTC) ONE TO THREE TIMES DAILY. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONEAPPLICATION 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 APPLICATON TO ONCE A DAY OR EVEN EVERY OTHER DAY. THE ACNE-STATIN CML IS FOR USE BETWEEN APPLICATIONS OF ACNE-STATIN TREATMENT CREAM (ACTC) TO HELP KEEP SKIN FEELING MOIST & SOFT.

AT NIGHT:

1. CLEANSE FACE WITH ACNE-STATIN CLEANSER/MOISTURIZER LOTION (CML), INSTEAD OF SOAP, TO REMOVE DIRT AND/OR MAKE-UP. WIPE WITH TISSUE. RINSE WITH WATER.
2. STEAM FACE.
3. PAT DRY.
4. RE-APPLY ACNE-STATIN CLEANSER/MOISTURIZER LOTION (CML) AND LEAVE IT ON ALL NIGHT.

INACTIVE INGREDIENT

PRESERVATIVES: METHYLPARABEN 0.15%, PROPYLPARABEN 0.1%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. KARRS ACNE-STATIN 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10258-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10258-102-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/21/2014

Labeler - COLONIAL DAMES CO LTD (008490385)