BOTANIC SKINCARE ACNE DEFENSE TREATMENT- salicylic acid lotion

Botanic Skincare Acne Defense Treatment by

Drug Labeling and Warnings

Botanic Skincare Acne Defense Treatment by is a Otc medication manufactured, distributed, or labeled by ElleGreen Health & Beauty Shop LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 2.00%

Acne Treatment

Use For:

For the treatment of Acne.

Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishen from forming.

Warnings

• For external use only.
• Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
• 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 per day.

Do not use

for prolonged periods without consulting a doctor

Keep out of reach of children

If swallowed, contact physician or poison control center immediately.

Store at room temperature.

Directions

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body.

• For best results apply one to three times per day.

Other Ingredients

ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, AQUA (DEIONIZED WATER), BUTYLENE GLYCOL, CAMELLIA SINENSIS (GREEN TEA) EXTRACT, CAMELLIA SINENSIS (WHITE TEA) EXTRACT, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE,
DMAE BITARTRATE, EMU OIL, GLYCERIN, GLYCRRHIZA GLABRA (LICORICE) EXTRACT, HYALURONIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, METHYLISOTHIAZOLINONE, POLYSORBATE-20, SODIUM PCA, XANTHAN GUM

Product Label

INGREDIENTS AND APPEARANCE

BOTANIC SKINCARE ACNE DEFENSE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69735-637
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
ALLANTOIN (UNII: 344S277G0Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DEANOL BITARTRATE (UNII: D240J05W14)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69735-637-30	1 in 1 CARTON	02/22/2017
1		30 mL in 1 JAR; 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	03/19/2015

Labeler - ElleGreen Health & Beauty Shop LLC (079760751)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(69735-637)