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NDC 71221-0995-06 EB5 Age Spot Treatment 20 mg/mL Details

EB5 Age Spot Treatment 20 mg/mL

EB5 Age Spot Treatment is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Elements Brands, Inc.. The primary component is HYDROQUINONE.

Product Information

NDC	71221-0995
Product ID	71221-995_dcf383ba-94c2-155d-e053-2995a90a5a75
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	EB5 Age Spot Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	HYDROQUINONE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	HYDROQUINONE
Labeler Name	Elements Brands, Inc.
Pharmaceutical Class	Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part358A
Listing Certified Through	n/a

Package

Package Images

NDC 71221-0995-06 (71221099506)

Pricing Information	N/A
NDC Package Code	71221-995-06
Billing NDC	71221099506
Package	1 TUBE in 1 BOX (71221-995-06) / 177.4 mL in 1 TUBE
Marketing Start Date	2018-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b70164e1-433c-420a-b848-1cbefa9278b3 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71221-995-06	1 in 1 BOX	12/15/2018	10/31/2023
1		177.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part358A	12/15/2018	10/31/2023

Labeler - Elements Brands, Inc. (006166707)

Revised: 4/2022

Document Id: dcf383ba-94c2-155d-e053-2995a90a5a75

Set id: b70164e1-433c-420a-b848-1cbefa9278b3

Version: 3

Effective Time: 20220418