TAKE CONTROL CALMING CLEANSER- salicylic acid gel

TAKE CONTROL CALMING by

Drug Labeling and Warnings

TAKE CONTROL CALMING by is a Otc medication manufactured, distributed, or labeled by mybody, OWEN BIOSCIENCES INC, COSMETIC ENTERPRISES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

SALICYLIC ACID 2%

PURPOSE

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE

USE FOR TREATMENT OF ACNE

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

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

ASK DOCTOR/PHARMACIST

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

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

OTHER INFORMATION

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

INACTIVE INGREDIENT

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

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TAKE CONTROL CALMING  CLEANSER
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49520-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
GINGER (UNII: C5529G5JPQ)
OAT (UNII: Z6J799EAJK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CURDLAN (UNII: 6930DL209R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
ACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49520-104-31	5 mL in 1 TUBE
2	NDC: 49520-104-15	150 mL in 1 BOTTLE
3	NDC: 49520-104-51	1 in 1 BOX
3	NDC: 49520-104-11	150 mL in 1 BOTTLE
4	NDC: 49520-104-33	10 mL in 1 TUBE
5	NDC: 49520-104-35	150 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/27/2012

Labeler - mybody (004460532)

Establishment
Name	Address	ID/FEI	Business Operations
OWEN BIOSCIENCES INC		790003045	manufacture(49520-104)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC ENTERPRISES LTD		017701475	repack(49520-104)