FDA Label for Pure Valley Miracle Age Spot
View Indications, Usage & Precautions
Pure Valley Miracle Age Spot Product Label
The following document was submitted to the FDA by the labeler of this product Concept Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
For external use only.
- avoid contact with eyes. If eye contact occurs flush thoroughly with water.
Manufactured by Concept Laboratories, Inc., Chicago, IL 60642 (USA)
Active Ingredient
Hydroquinone 1.5%
Purpose
Skin Lightener
Uses
for the gradual fading of dark (brownish) discolorations in the skin such as
- freckles
- age and liver spots
- pigment in the skin that may occur in pregnancy or from the use of oral contraceptives
Otc - Stop Use
- some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor
Otc - Do Not Use
- do not use on children under 12 years of age unless directed by a doctor
Otc - Pregnancy Or Breast Feeding
- if pregnant or nursing, seek the advice of a health professional before using
Otc - When Using
When using this product do not use on cracked, irritated or inflamed skin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
- if swallowed, get medical help or contact a Poison Control Center right away
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.
- for sensitive skin, test product on a small section of your skin inside your elbow
Inactive Ingredients
Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Mineral Oil, Ceteareth-20, Isopropyl Myristate, Glycerin, Petrolatum, Butyrospermum Parkii (Shea Butter), Sodium Metabisulfite, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Citric Acid, Glycolic Acid, Ascorbic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Disodium EDTA, Fragrance.
Other Information
- For sensitive skin, test product on a small section of your skin inside your elbow. If no irritation develops after 24 hours proceed with application.
- Close product lid tightly after each use. Cream may darken when exposed to air. Product performance will not be affected.
- Do not use this product in combination with externally applied products containing resorcinol, phenol, salicylic acid or any type of acne product unless directed by a doctor.
- Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Questions Or Comments?
Call 1-888-373-8831 or visit www.conceptlabs.org
Principal Display Panel - 113 G Jar Label
PURE VALLEY®
Miracle–Age Spot
FADE CREME
Skin Lightening
with Alpha Hydroxy Acids & Shea Butter
4oz. (113g)e
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