ACNE ADVANCED CLARIFYING HYDRATOR- salicylic acid cream

Acne Advanced Clarifying Hydrator by

Drug Labeling and Warnings

Acne Advanced Clarifying Hydrator by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

• For the treatment of acne.

Warnings

For external use only

When using this product

• Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, use only one product at a time.
• avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contaact Poison Control Center right away.

Direcitons

• Cleanse skin thoroughly before applying this product 
• Apply a layer over the entire face and neck 1 to 3 times daily and leave on.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 ot 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed. 

Inactive ingredients

Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) Peel Extract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol, Citrus Grandis (Grapefruit) Peel Oil, Mentha Spicata (Spearmint) Leaf Oil, Sodium Acrylate, Nyphaea Caerulea (Blue Lotus) Flower Extract, Nelumbo Nucifera (Sacred Lotus) Flower Extract, Origanum Vulgare (Oregano) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium (Cinnamon) Bark Extract, Olea Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5), Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate, Arbutin, Cocamidopropyl Dimethylamine, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)

*Certified organic ingredient

Acne Advanced Clarifying Hydrator 1.2oz Box (

15751-3030-2)

Acne Advanced Clarifying Hydrator 1.2oz Bottle (

15751-3030-2)

Acne Advanced Clarifying Hydrator 1.9oz (

15751-3030-9)

INGREDIENTS AND APPEARANCE

ACNE ADVANCED CLARIFYING HYDRATOR 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-3030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
CUCUMBER (UNII: YY7C30VXJT)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
GRAPEFRUIT (UNII: O82C39RR8C)
SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G)
PEPPERMINT (UNII: V95R5KMY2B)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BETA VULGARIS (UNII: 4G174V5051)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
PROPANEDIOL (UNII: 5965N8W85T)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
SPEARMINT (UNII: J7I2T6IV1N)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
OREGANO (UNII: 0E5AT8T16U)
THYME (UNII: CW657OBU4N)
CINNAMON (UNII: 5S29HWU6QB)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSEMARY (UNII: IJ67X351P9)
GOLDENSEAL (UNII: ZW3Z11D0JV)
LEMON (UNII: 24RS0A988O)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOHEXADECANE (UNII: 918X1OUF1E)
NIACIN (UNII: 2679MF687A)
ALLANTOIN (UNII: 344S277G0Z)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARBUTIN (UNII: C5INA23HXF)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
SOYBEAN OIL (UNII: 241ATL177A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SORBIC ACID (UNII: X045WJ989B)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ACAI (UNII: 46AM2VJ0AW)
CARROT (UNII: L56Z1JK48B)
COCONUT (UNII: 3RT3536DHY)
STARCH, TAPIOCA (UNII: 24SC3U704I)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-3030-2	1 in 1 BOX	09/01/2018
1		35 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 15751-3030-9	55 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/01/2018

Labeler - Eminence Organic Skin Care Ltd. (205753317)