Your browser does not support JavaScript! TAKE CONTROL CALMING CLEANSER (SALICYLIC ACID) GEL [MYBODY]
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TAKE CONTROL CALMING CLEANSER (salicylic acid) gel
[mybody]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

SALICYLIC ACID 2%

PURPOSE

ACNE TREATMENT

USE FOR TREATMENT OF ACNE

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE * IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF *PREGNANT OR LACTATING. YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

WHEN USING THIS PRODUCT * AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. * KEEP AWAY FROM LIPS AND MOUTH.

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

DIRECTIONS

* USE AM/PM OR AS DIRECTED BY A DOCTOR. APPLY A NICKEL-SIZE AMOUNT TO WET HANDS. RUB TOGETHER. GENTLY MASSAGE ONTO FACE AND NECK WITH CIRCULAR MOTIONS. LEAVE ON 1-2 MINUTES THEN RINSE WELL.

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

INACTIVE INGREDIENTS: WATER, DISODIUM LAURETH SULFOSUCCINATE, SODIUM COCOYL ISETHIONATE, SODIUM LAUROAMPHOACETATE, GLYCERIN, SODIUM METHYL COCOYL TAURATE, METHYLISOTHIAZOLINONE, COCAMIDOPROPYL BETAINE, BISABOLOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, OAT (AVENA SATIVA) KERNEL EXTRACT, DISODIUM EDTA, BETA GLUCAN, EUCALYPTUS GLOBULUS OIL, XANTHAN GUM, MENTHOL, MYRISTOYL TETRAPEPTIDE-13, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL.

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

5-8 x 2_5ml Die-Line_TAKE CONTROL_V3_1.6.12Take Control ART_Drug Facts Box

TAKE CONTROL CALMING  CLEANSER
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49520-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DISODIUM LAURETH SULFOSUCCINATE 
SODIUM COCOYL ISETHIONATE 
SODIUM LAUROAMPHOACETATE 
GLYCERIN 
SODIUM METHYL COCOYL TAURATE 
METHYLISOTHIAZOLINONE 
COCAMIDOPROPYL BETAINE 
.ALPHA.-BISABOLOL, (+/-)- 
GINGER 
OAT 
EDETATE DISODIUM 
CURDLAN 
EUCALYPTUS OIL 
XANTHAN GUM 
MENTHOL 
MYRISTOYL PENTAPEPTIDE-4 
ACETYL CARBOXYMETHYL COCOYL GLYCINE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49520-104-315 mL in 1 TUBE
2NDC:49520-104-15150 mL in 1 BOTTLE
3NDC:49520-104-511 in 1 BOX
3NDC:49520-104-11150 mL in 1 BOTTLE
4NDC:49520-104-3310 mL in 1 TUBE
5NDC:49520-104-35150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/27/2012
Labeler - mybody (004460532)
Establishment
NameAddressID/FEIBusiness Operations
OWEN BIOSCIENCES INC790003045manufacture(49520-104)
Establishment
NameAddressID/FEIBusiness Operations
COSMETIC ENTERPRISES LTD017701475repack(49520-104)

Revised: 12/2013
 
mybody

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