NATURAL ACNE SOLUTIONS 3 STEP REGIMEN- salicylic acid kit

Natural Acne Solutions 3 Step Regimen by

Drug Labeling and Warnings

Natural Acne Solutions 3 Step Regimen by is a Otc medication manufactured, distributed, or labeled by Burt's Bees. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

SALICYLIC ACID 1.0%

Purpose

Acne Treatment

INDICATIONS & USAGE

PENETRATES PORES TO CONTROL ACNE.

HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES

WARNINGS

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY 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 IF SWALLOWED, GET MEDICATL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY TO FACE IN THE MORNING AND EVENING AFTER CLEANSING. IF BOTHERSOME DRYNESS OCCURS, REDUCE TO ONCE A DAY OR EVERY OTHER DAY.

INACTIVE INGREDIENTS

WATER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, STEARIC ACID, SUCROSE POLYSTEARATE, SALIX NIGRA (WILLOW) BARK EXTRACT, BEESWAX, CYMBOPOGON SCHOENANTHUS EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, HUMULUS LUPULUS (HOPS) EXTRACT, EQUISETUM HIEMALE EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, EPILOBIUM FLEISCHERI EXTRACT, LECITHIN, CHONDRUS CRISPUS (CARAGEENAN), FRAGRANCE, GLUCOSE, XANTHAN GUM, SUCROSE, SUCROSE STEARATE, POTASSIUM SORBATE, SODIUM CHLORIDE, GLUCOSE OXIDASE, LACTOPEROXIDASE, PHENOXYETHANOL.

QUESTIONS?

800-849-7112 OR WWW.BURTSBEES.COM

ACTIVE INGREDIENTS

SALICYLIC ACID 1.0%

PURPOSE

ACNE TREATMENT

USES

PENETRATES PORES TO CONTROL ACNE.

HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES.

WARNINGS

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION WHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Keep out of reach of children. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

WASH FACE IN THE MORNING AND EVENING AVOIDING THE EYE AREA. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

QUESTIONS?

800-849-7112 OR WWW.BURTSBEES.COM

INACTIVE INGREDIENTS

WATER, DECYL GLUCOSIDE, LAURYL GLUCOSIDE, SUCROSE LAURATE, SALIX NIGRA (WILLOW) BARK EXTRACT, COCO-BETAINE, BETAINE, BETA VULGARIS (BEET) ROOT EXTRACT, CENOTHERA BIENNIS (EVENING PRIMROSE) LEAF EXTRACT, SODIUM COCOYL HYDROLYZED SOY PROTEIN, HYDROXYPROPYLTRIMONIUM HONEY, GLYCERIN, GLYCERYL OLEATE, COCO GLUCOSIDE, FRAGRANCE, GLUCOSE, ALCOHOL DENAT., GLUCOSE OXIDASE, LACTOPEROXIDASE, CITRIC ACID, SODIUM CHLORIDE, PHENOXYETHANOL.

ACTIVE INGREDIENT

Salicylic Acid 0.75%

PURPOSE

Acne Treatment

Uses

• Penetrates pores to control acne

Warnings

For external use only. Using other topical acne medication at the same time or immediately following use of this product may increased 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. If swallowed, get medical help and contact a Poison Control Center right away.

Directions

Apply to face in the morning and evening after cleansing.

Inactive Ingredients

Inactive Ingredients: alcohol denat., citrus medica limonum (lemon) peel oil, water, achillea millefolium extract, borago officinalis extract, calendula officinalis flower extract, carum petroselinum (parsley) extract, foeniculum vulgare (fennel) oil, salix nigra (willow) bark extract, melaleuca alternifolia (tea tree) leaf oil, eucalyptus globulus leaf oil, juniperus communis fruit oil

QUESTIONS

Questions? 800-849-7112 or www.burtsbees.com

PRINCIPAL DISPLAY PANEL

BURTS BEES

Natural

ACNE SOLUTIONS

1 Purifying Gel Cleanser

2 Daily Moisturizing Lotion

3 Targeted Spot Treatment

3 Step Regimen Kit Salicylic Acid Acne Treatment from Willow Bark

INGREDIENTS AND APPEARANCE

NATURAL ACNE SOLUTIONS 3 STEP REGIMEN 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-035

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-035-10	1 in 1 BOX; Type 0: Not a Combination Product	01/02/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE, PLASTIC	1 mL  in 100
Part 2	0 BOTTLE, WITH APPLICATOR	1 g  in 100
Part 3	0 BOTTLE, PUMP	1 g  in 100

Part 1 of 3

NAS PURIFYING CLEANSER 
salicylic acid gel

Product Information
Item Code (Source)	NDC: 26052-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL OLEATE (UNII: 4PC054V79P)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SUCROSE LAURATE (UNII: 05Q7CD0E49)
COCO GLUCOSIDE (UNII: ICS790225B)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYLTRIMONIUM CHLORIDE FRAGMENT (UNII: N30M4819DB)
BETA VULGARIS (UNII: 4G174V5051)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
ALCOHOL (UNII: 3K9958V90M)
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
COCO-BETAINE (UNII: 03DH2IZ3FY)
BETAINE (UNII: 3SCV180C9W)
OENOTHERA BIENNIS LEAF (UNII: 153YBS895W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-010-02	145 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/01/2010

Part 2 of 3

NAS TARGETED SPOT TREATMENT 
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 26052-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LEMON OIL (UNII: I9GRO824LL)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
PARSLEY OIL (UNII: IXK9N7RJ7J)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
TEA TREE OIL (UNII: VIF565UC2G)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
FENNEL OIL (UNII: 59AAO5F6HT)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
ALCOHOL (UNII: 3K9958V90M)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-011-03	7.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/01/2010

Part 3 of 3

NAS DAILY MOISTURIZING 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 26052-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
LEVOGLUCOSE (UNII: 02833ISA66)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
EPILOBIUM FLEISCHERI WHOLE (UNII: 8E2KLS8J8K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
WHITE WAX (UNII: 7G1J5DA97F)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCROSE STEARATE (UNII: 274KW0O50M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
EQUISETUM HYEMALE (UNII: 59677RXH25)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SUCROSE (UNII: C151H8M554)
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-012-01	55 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/02/2014

Labeler - Burt's Bees (613480946)