OTC Medication Information: AGELESS Total Skin Bleaching Serum

AGELESS TOTAL SKIN BLEACHING SERUM — hydroquinone liquid
Allure Labs, 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 INGREDIENTS:
Hydroquinone: 2%

INACTIVE INGREDIENTS:

Water, Glycolic Acid, Citric Acid, Phytic Acid, Azelaic Acid, Aloe Barbedensis Leaf Extract, Phyenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Trea) Leaf Oil, Xanthan Gum, Mentha Virdis (Spearmint) Oil, Eucaluptus Globulus Leaf Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Pineapple-Coconut Enzyme.

Other Information on the back of the container:

(Claims)

An oil-free hydroquinone/glycolic acid serum that gently lightens skin discolorations. Daily application lightens melasma, freckeles and other areas of melanin hyperpigmention.

Paraben-free

Directions:

Apply to cleansed skin morning and evening.

Indications:

Freckles, melasma, post pregnancy pigmentation disorders, hand discolorations.


Distributor:

Image International

Palm Beach, FL 33411 USA

www.imageskincare.com

Image of the Product (Front): AGELESS Total Skin Bleaching Serum

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AGELESS TOTAL SKIN BLEACHING SERUM
hydroquinone liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4033
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 20 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4033-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358 01/01/2010
Labeler — Allure Labs, Inc. (926831603)

Revised: 07/2010 Allure Labs, 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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