CLEAR ACNE FACE MOISTURIZER- acne face moisturizer lotion

Clear Acne Face Moisturizer by

Drug Labeling and Warnings

Clear Acne Face Moisturizer by is a Otc medication manufactured, distributed, or labeled by Kamedis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic acid 2.0%

Purpose

Acne Treatment

Use

• For the treatment of acne

Warnings

For external use only

When using this product

• Avoid unnecessary sun exposure and use
  sunscreen.
• Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.

Stop use and ask a doctor

• If irritation persists

Keep out of reach of children

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

Directions

• Cleanse the skin thoroughly before applying medication.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
• For children under 10 years of age, consult your physician.

Inactive Ingredients

Alcohol, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Tetraisopalmitate, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Behenyl Alcohol, Benzyl Alcohol, Capryloyl Glycine, Carbomer, Cetyl Alcohol, Chlorphenesin, Chinese Rhubarb (Rheum Palmatum) Root Extract, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Dicaprylyl Carbonate, Fragrance, Glucose, Glycerin, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Phenethyl Alcohol, Plankton Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Shea Butter (Butyrospermum Parkii), Sodium Hydroxide, Sodium Phytate, Squalane, Stearyl Alcohol, Water, Xanthan Gum.

Questions or Comments?

1-855-626-6606

SPL UNCLASSIFIED SECTION

Made in USA
Manufactured for Kamedis
Pennsylvania, 18109
1-855-626-6606

www.kamedis-usa.com

Carton label

INGREDIENTS AND APPEARANCE

CLEAR ACNE FACE MOISTURIZER 
acne face moisturizer lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50718-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	28.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ALCOHOL (UNII: 3K9958V90M)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CETYL ALCOHOL (UNII: 936JST6JCN)
PURSLANE (UNII: M6S840WXG5)
CHLORPHENESIN (UNII: I670DAL4SZ)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PICEA ABIES WOOD (UNII: 72GZ8K8996)
PROPANEDIOL (UNII: 5965N8W85T)
SARCOSINE (UNII: Z711V88R5F)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CINNAMON BARK OIL (UNII: XE54U569EC)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTATE SODIUM (UNII: 88496G1ERL)
SQUALANE (UNII: GW89575KF9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
NORI (UNII: 477TV3P5UX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50718-0033-1	1 in 1 CARTON	01/01/2018
1		50 mL in 1 BOTTLE; 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	01/01/2018

Labeler - Kamedis (533176319)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(50718-0033)