EB5 AGE SPOT TREATMENT- hydroquinone cream

EB5 Age Spot Treatment by

Drug Labeling and Warnings

EB5 Age Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Elements Brands, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin lightener

Uses

Lightens dark spots in the skin such as freckles, age spots an liver spots.

Warnings

• For external use only.
• Avoid contact with eyes or eyelids.
• Some users of this product may experience milld skin irritation. Consult physician if skin irritation becomes severe.

Do not use 

• on children under 12, unless directed by physician

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

SPL UNCLASSIFIED SECTION

Store at room temperature.

Directions

• Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.
• Lightening effect of this product may not be noticeable when used on very dark skin.
• Children under 12 years of age: do not use unless directed by a doctor.
• Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from recurring.

Other Ingredients:

Acer Saccharum (Sugar Maple) Extract, Aminomethyl Propanol, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Caprylic/Capric/Myristic/Stearic Triglyceride, Carbomer, Cetearyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Octisalate, Oleth-5 Phosphate, Phenoxyethanol, Saccharum Officinarum (Sugar Cane) Extract, Sodium Metabisulfite, Steareth-21, Stearyl Alcohol, Vaccinium Myrtillus (Bilberry) Extract.

Question of Comments?

1-800-683-2325, M-F, 8am-5pm PST.

Package Labeling:

INGREDIENTS AND APPEARANCE

EB5 AGE SPOT TREATMENT 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71221-995
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
OCTISALATE (UNII: 4X49Y0596W)
OLETH-5 PHOSPHATE (UNII: 44FE98F6UX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SUGARCANE (UNII: 81H2R5AOH3)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BILBERRY (UNII: 9P2U39H18W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71221-995-06	1 in 1 BOX	12/15/2018
1		177.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	12/15/2018

Labeler - Elements Brands, Inc. (006166707)