CHARCOAL ACNE SCRUB HELP CLEAR ACNE BLEMISHES- salicylic acid gel

Charcoal Acne Scrub by

Drug Labeling and Warnings

Charcoal Acne Scrub by is a Otc medication manufactured, distributed, or labeled by Greenbrier International Inc., China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose

Acne treatment

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 1%

DOSAGE & ADMINISTRATION

Directions

• Wet face
• Squeeze product into hands
• Massage over entire face and rinse thoroughly
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directly by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, GLYCERIN, SORBITOL, SYNTHETIC WAX, MICROCRYSTALLINE WAX, CHARCOAL POWDER, XANTHAN GUM, SODIUM BENZOATE, FRAGRANCE, POLYQUATERNIUM-39, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA, MENTHOL, SODIUM HYDROXIDE

WARNINGS

Warnings

For external use only

When using this product

• Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, oinly use one topical acne medication at a time.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water

INDICATIONS & USAGE

Use

• For the treatment of acne
• Clears up acne blemishes, blackheads and whiteheads
• Penetrates pores to control acne blemishes
• Helps prevent new acne blemishes from forming

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHARCOAL ACNE SCRUB  HELP CLEAR ACNE BLEMISHES
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-3036
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITOL (UNII: 506T60A25R)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
XANTHAN GUM (UNII: TTV12P4NEE)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MENTHOL (UNII: L7T10EIP3A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-3036-1	91 g in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/16/2018

Labeler - Greenbrier International Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(33992-3036)