Your browser does not support JavaScript! SANTALIA CLINICAL ACNE (SALICYLIC ACID) KIT [SANTALIS PHARMACEUTICALS]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

SANTALIA CLINICAL ACNE (salicylic acid) kit
[Santalis Pharmaceuticals]


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

Daily Cleanser                                   

Active Ingredient: Salicylic Acid  0.5%

Daily Serum

Active Ingredient:   Salicylic Acid  0.5%

Spot Treatment

Active Ingredient:   Salicylic Acid 2%

Purpose:  Acne Treatment

Use

For the Treatment of Acne

Warnings For external Use Only

When Using this product,
using other topical acne products at the same time or immediately following the use of this product may increase or irritation of the skin.  If this occurs, only one product should be used unless directed by a physician.


Keep Out of reach of Children.  If swallowed, get medical help or contact a Poison Control Center right away.

Do not use around eye area.  If contact occurs, flush thoroughly with water.  If irritation develops, discontinue use.

Directions

Daily Cleanser:

Apply foam to wet face with washcloth or very soft brush am and pm.  Rinse thoroughly with cool water and pat dry.  Use on neck and chest as needed.

Daily Serum

Apply to cleansed skin am and pm.  For maintenance, use once a day. Treat individual blemishes with SANTALIA SPOT TREATMENT as needed.

Intensive Spot Treatment

Apply to Blemishes as needed, up to 3 times a day.

Daily Cleanser

Inactive ingredients  WATER, LAURAMIDOPROPYL BETAIN, SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE, POLYSORBATE 80, GLYCERIN, TERMINALIA FERDINANDIANA FRUIT EXTRACT, ALCOHOL, BUTYLENE GLYCOL, BACKHOUSIA CITRIODORA LEAF EXTRACT, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) EXTRACT, CITRIC ACID SANTALUM ALBUM WOOD OIL, FUSANUS SPICATUS WOOD OIL, TANGERINE OIL, GRAPEFRUIT OIL.

Daily Serum

Inactive Ingredients:  WATER, ISODECYL NEOPENTANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, FUSANUS SPICATUS WOOD OIL, SANTALUM ALBUM WOOD OIL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7 HYDROLYZED ALGIN, ZINC SULFATE, GLYCERIN, TERMINALIA FERDINANDIANA FRUIT EXTRACT, ALCOHOL, BUTYLENE GLYCOL, BACKHOUSIA CITRIODORA LEAF EXTRACT, LONICERA CAPRIFOLIUM (HONEYSUCKLE) FLOWER EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) EXTRACT, CITRIC ACID, BUTYL AVOCADATE, FUSANUS SPICATUS NUT OIL.

Intensive Spot Treatment

Inactive Ingredients: SD ALCOHOL 40-B, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, FUSANUS SPICATUS WOOD OIL, SANTALUM ALBUM WOOD OIL, HYDROXYPROPYLCELLULOSE, BUTYLENE GLYCOL, ALLIUM CEPA BULK EXTRACT, BACKHOUSIA CITRIODORA LEAF EXTRACT, OCTYLDODECANOL, CARDIOSPEMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, ECHIUM PLATAFINEUM SEED OIL, WATER, HELIANTHUS ANNUUS (SUNFLOWER) SEE OIL UNSAPONIFIABLES.

Questions or Comments?  1-800-397-0546

MM1

SANTALIA CLINICAL ACNE 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76358-196
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76358-196-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 120.0 mL
Part 21 TUBE 15.0 mL
Part 31 TUBE 30.0 mL
Part 1 of 3
SANTALIA CLINICAL DAILY CLEANSER 
salicylic acid soap
Product Information
Item Code (Source)NDC:76358-195
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.54 g  in 100.00 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TERMINALIA BELLIRICA FRUIT 
1,3-BUTYLENE GLYCOL 
ALCOHOL 
BACKHOUSIA CITRIODORA LEAF 
PHENOXYETHANOL 
SODIUM LAURYL SULFATE 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
CITRIC ACID MONOHYDRATE 
LAURAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
DMDM HYDANTOIN 
POLYSORBATE 80 
SANTALUM SPICATUM OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76358-195-02120.0 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2013
Part 2 of 3
SANTALIA CLINICAL INTENSTIVE SPOT TREATMENT 
salicylic acid gel
Product Information
Item Code (Source)NDC:76358-192
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2.18 g  in 100.00 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
SANTALUM SPICATUM OIL 
1,3-BUTYLENE GLYCOL 
WATER 
BACKHOUSIA CITRIODORA LEAF 
PHENOXYETHANOL 
ONION 
OCTYLDODECANOL 
ECHIUM PLANTAGINEUM SEED OIL 
SUNFLOWER OIL 
CARDIOSPERMUM HALICACABUM FLOWERING TOP 
TOCOPHEROL 
HAMAMELIS VIRGINIANA TOP WATER 
BENZOIC ACID 
HYDROXYPROPYL CELLULOSE (TYPE H) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76358-192-0115.0 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2013
Part 3 of 3
SANTALIA CLINICAL DAILY SERUM 
salicylic acid gel
Product Information
Item Code (Source)NDC:76358-194
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.54 g  in 100.00 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
1,3-BUTYLENE GLYCOL 
ALCOHOL 
SODIUM ALGINATE 
ZINC SULFATE 
BACKHOUSIA CITRIODORA LEAF 
PHENOXYETHANOL 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
CITRIC ACID MONOHYDRATE 
MEDIUM-CHAIN TRIGLYCERIDES 
ISODECYL NEOPENTANOATE 
AVOCADO 
SANTALUM SPICATUM OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76358-194-0130.0 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/01/2013
Labeler - Santalis Pharmaceuticals (963047027)

Revised: 6/2014
 
Santalis Pharmaceuticals

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services