OTC Medication Information: Alba Acnedote Clean Treat Towelette

ALBA ACNEDOTE CLEAN TREAT TOWELETTE- salicylic acid cloth
The Hain Celestial Group, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Salicylic Acid 2.0%

Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application.

Acne Treatment

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate,, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient; (2) For scent only

For the treatment of acne.

pouch label
(click image for full-size original)

ALBA ACNEDOTE CLEAN TREAT TOWELETTE
salicylic acid cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2765
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g in 30
Inactive Ingredients
Ingredient Name Strength
SODIUM CETOSTEARYL SULFATE
POTASSIUM SORBATE
GLYCYRRHIZA GLABRA
BERGAMOT OIL
SALIX ALBA BARK
WATER
GLYCERIN
ALOE VERA LEAF
ORANGE OIL
PROPANEDIOL
MEDIUM-CHAIN TRIGLYCERIDES
C14-22 ALCOHOLS
PEPPERMINT OIL
HAMAMELIS VIRGINIANA TOP WATER
PARSLEY
CHAMOMILE
MELISSA OFFICINALIS LEAF
C12-20 ALKYL GLUCOSIDE
CETOSTEARYL ALCOHOL
ANHYDROUS CITRIC ACID
POTASSIUM HYDROXIDE
XANTHAN GUM
BENZOIC ACID
PHENOXYETHANOL
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-2765-4 30 CLOTH in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/26/2013
Labeler — The Hain Celestial Group, Inc. (858894996)
Registrant — The Hain Celestial Group, Inc. (858894996)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 858894996 manufacture (61995-2765)

Revised: 11/2014 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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