Otc - Active Ingredient
Active Ingredient
Sulfur 10%
Anna Guanche Md Miracle Cream The Pimple Cream
FDA Label NDC 80841-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bella Cosmeceuticals, Inc. for the product Anna Guanche Md Miracle Cream The Pimple Cream (NDC 80841-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acne Treatment
Warnings
For external use only.
Otc - When Using
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
- if irritation occurs, only use one topical acne medication at a time.
- avoid contact with eyes. If contact occurs, flush thoroughly with water.
- apply only to areas with acne.
Otc - Stop Use
Stop use and ask a doctor if skin irritation or redness develops.
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.
Indications & Usage
Uses
- For Treatment of acne
Dosage & Administration
Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to two times daily
- because excessive drying of the skin may occur, start with one application daily then gradually increase to two times daily if needed
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Sensitivity Test for New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomforts occurs, follow directions stated above.
or as directed by a doctor.
Storage And Handling
Other information Store at 68°F- 77°F (20°C- 25°C).
Inactive Ingredient
Inactive ingredients Water ( Aqua), Helianthus Annuus (Sunflower) Seed Oil, Dicaprylyl Carbonate, Acacia Senegal Gum, Squalane, Glycerin, Calamine, Shea Butter, Glycerides, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, PEG-100, Stearane, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Bisabolol, Tocopheryl Acetate, Magnolia Officinalis Bark Extract, Hydroxyphenyl Propamidobenzoic Acid, Stearic Acid, Ethylhexylglycerin, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Pentylene Glycol, Disodium EDTA, Butylene Glycol, Caprylyl Glycol, Penoxyethanol, Fragrance (Parfum)
Otc - Do Not Use
Do not use on
- broken skin
- large areas of the skin
Otc - Questions
Call 818-324-4339 or visit www.miraclecreambybella.com
Package Label.Principal Display Panel
Mcip2 (Mcip2)
Mcfp (Mcfp)
Mcip1 (Mcip1)
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