DERMACLEAR SERUM- salicylic acid cream

DermaClear Serum by

Drug Labeling and Warnings

DermaClear Serum by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

Salicylic Acid - 2%

PURPOSE

Purpose: Acne Treatment

INDICATIONS & USAGE

Uses:

For the treatment of acne

WARNINGS

Warnings:

For external use only

WHEN USING

• Avoid contact with the eyes, lips and mouth
• Using other topical acne medications 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.
• If sensitive to the sub or when increased sun exposure is expected use a sunscreen.
  

STOP USE

• If severe skin irritation occurs.
• Using other topical medication at the same time
  

KEEP OUT OF REACH OF CHILDREN

• If swallowed, get medical help or contact a Poison Control Center right away.
  

DOSAGE & ADMINISTRATION

Directions

• Apply a small portion over the affected area with finger tips and gently massage onto the skin.
• Reapply as needed
  

INACTIVE INGREDIENT

Water (Aqua), SD Alcohol 40B, Glycolic Acid, Caprylic / Capric Triglyceride, Azelaic Acid, Glycerin, Hexyl Laurate, Cetearyl Olivate, Butylene Glycol, Sorbitol, Lactic Acid, Sorbitan Olivate, PPG-12 /SMDI Copolymer, Niacinamide, Cetyl Alcohol, Sodium Hyaluronate, Dicetyl Phosphate, Ceteth-10 Phosphate, Srearic Acid, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indiaca (Mango) Seed Butter, Dimethicone, Ethyl Linoleate, Hexylrsorcinol, Yeast Ploysaccharides, Propylene Glycol., Symphytum Officinales Rhizome/Root Extract, Plantago Ovata Seed Extract, Glutamine, Proline, Leucine, Serine, Hedera, Helix (Ivy) Leaf/Stem Extract, Cucumis Sativus Fruit Extract, Sambucus Nigra Flower Extract, Arnica Montana Flower Extract, Parietaria Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Lavandula Angustifoia  (Lavender) Oil, Imperata  Cylindrica  (Root) Extract, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract,  Achillea  Mellifolium Extract, Hydrolyzed Vegetable Protein, Glycosaminoglycans, Salix Alba (Willlow) Bark Extract, Arcaptostaphylos, Uva Ursi Leaf Extract, Mitracarpus Scaber Extract, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid. Glycerin, Hydrolyzed wheat Protein, Hydrolyzed Wheat Starch, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Xanthan Gum, Magnesium Aluminum Silicate, Ammonium Hydroxide, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

Manufactured for Dermaquest Inc
Hayward, CA 94544
1272 GK, NL Made in USA
dermaquestinc.com

INGREDIENTS AND APPEARANCE

DERMACLEAR SERUM 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AZELAIC ACID (UNII: F2VW3D43YT)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITOL (UNII: 506T60A25R)
LACTIC ACID (UNII: 33X04XA5AT)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER (UNII: K49155WL9Y)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COMFREY ROOT (UNII: M9VVZ08EKQ)
PLANTAGO OVATA SEED (UNII: UD50RBY30F)
GLUTAMINE (UNII: 0RH81L854J)
PROLINE (UNII: 9DLQ4CIU6V)
LEUCINE (UNII: GMW67QNF9C)
SERINE (UNII: 452VLY9402)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
CUCUMBER (UNII: YY7C30VXJT)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
PARIETARIA OFFICINALIS LEAF (UNII: W2I83529KR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAVENDER OIL (UNII: ZBP1YXW0H8)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
PRIMULA VERIS (UNII: W6LFQ57E4M)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
GAG (UNII: U5T7CTT5KM)
SALIX ALBA BARK (UNII: 205MXS71H7)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
AMMONIA (UNII: 5138Q19F1X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4069-2	1 in 1 CARTON
1	NDC: 62742-4069-1	29.6 mL in 1 TUBE; 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	05/30/2014

Labeler - Allure Labs, Inc (926831603)