NATURAL PEELING TRIACTIVE ACNE- salicylic acid lotion 
Casmara Cosmetics, SA

Disclaimer: 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.

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Natural Peeling Tri Active. Acne treatment lotion

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

. keep out of reach of children

Questions or Comments?

Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

. keep the product in a cool and dry place

Directions

. clean the skin thoroughly before applying this product

. cover the entire affected area with a thin layer one to three times daily, massage the area and rinse thoroughly.

. because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

. clean the skin thoroughly before applying this product

. cover the entire affected area with a thin layer one to three times daily, massage the area and rinse thoroughly.

. because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

Uses

. helps keep the skin clear of new blakcheads

. acne treatment lotion

. helps the skin clear of new blackheads

Active Ingredients

Salicylic acid 0.5%........................... Acne Treatment

water, propylene glycol, glycolic acid, sodium hydroxide, lactic acid, carbomer 934, fragrance.

Box 1

For external use only.

Do not use on damaged or broken skin.

Avoid use around the eyes

Do not sunbathe after application

Stop use and ask a doctor if rash occurs.

Children under 6 months: as a doctor.

KEEP OUT OF THE REACH OF CHILDREN

USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR INMEDIATELY FOLLOWING THE 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

Sensitive Test for a New User

Apply product sparingly to one or two small affected areas during the first three days. If not discomfort occurs follow the directions state above in this label.

Natural Peeling Tri Active

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Bottle 1

NATURAL PEELING TRIACTIVE ACNE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 48.5 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg  in 1 mL
CARBOMER 934 (UNII: Z135WT9208) 1.5 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T) 40 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) 5.6 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 2 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT) 1.8 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-076-02150 in 1 BOX07/03/2016
1NDC:20151-076-01150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/03/2016
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-076)

Revised: 11/2016
Document Id: 403911b5-bc97-3734-e054-00144ff8d46c
Set id: 36c5281f-271f-58af-e054-00144ff88e88
Version: 2
Effective Time: 20161101
 
Casmara Cosmetics, SA