DERMACLEAR SPOT TREATMENT- benzoyl peroxide cream

Dermaclear Spot Treatment by

Drug Labeling and Warnings

Dermaclear Spot Treatment 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 - Benzoyl Peroxide 10%

PURPOSE

Purpose: Acne Treatment

INDICATIONS & USAGE

Uses:

• For the treatment of acne

WARNINGS

Warnings:

• For external use only

WHEN USING

When using this product:

• 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 sun or when increased sun exposure is expected use a sunscreen.
  

STOP USE

Stop use and ask a doctor:

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If swallowed, get medical help or contact a Poison Control Centre 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),Propylene Glycol, Glycerin, Sorbitol, Dimethyl Sulfone, PEG-8/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Carbomer, Triethanolamine, Collidal Silver, Salix Alba (Willow) Bark Extract, Malva Sylvestns (Mallow) Extract, Mentha Pipenta (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis  Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Melia Azadirachta Leaf Extract, Butylene Glycol, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Leptospermum Scoparium Branch/ Leaf Oil, Enantia Chlorantha Bark Extract, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Disodium EDTA

PRINCIPAL DISPLAY PANEL

Manufactured for

DermaQuest iNC,.

Hayward, CA  94544 1272 GK, NL

Made in USA

dermaquestinc.com

INGREDIENTS AND APPEARANCE

DERMACLEAR SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TROLAMINE (UNII: 9O3K93S3TK)
SILVER (UNII: 3M4G523W1G)
SALIX ALBA BARK (UNII: 205MXS71H7)
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)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
MASOPROCOL (UNII: 7BO8G1BYQU)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
TEA TREE OIL (UNII: VIF565UC2G)
MANUKA OIL (UNII: M6QU9ZUH2X)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4075-2	1 in 1 CARTON
1	NDC: 62742-4075-1	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	05/05/2015

Labeler - Allure Labs, Inc (926831603)