Anna Guance Md Miracle Cream The Pimple Cream

Anna Guance Md Miracle Cream The Pimple Cream
SPL v5
SPL
SPL Set ID b4562cf4-aae3-e9db-e053-2995a90a7210
Route
TOPICAL
Published
Effective Date 2025-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (100 mg)
Inactive Ingredients
Butylene Glycol Pentylene Glycol Hydroxyethyl Cellulose (100 Mpa.s At 2%) Glycerin Lonicera Japonica Flower Isopropyl Alcohol Lonicera Caprifolium Flower Dimethicone Peg-120 Glyceryl Stearate Tea Tree Oil .alpha.-bisabolol, (+)- Peg-100 Stearate Water Dicaprylyl Carbonate Cetyl Alcohol .alpha.-tocopherol Acetate, D- Hydroxyphenyl Propamidobenzoic Acid Stearic Acid Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Caprylyl Glycol Magnolia Officinalis Bark Hexylene Glycol Phenoxyethanol Ethylhexylglycerin Sunflower Oil Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-17

Description

Active Ingredient Sulfur 10%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses

  • For Treatment of acne
Dosage and 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

or as directed by a doctor.

  • 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.
Description

Active Ingredient Sulfur 10%

Section 44425-7

Other information Store at 68°F- 77°F (20°C- 25°C).

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if skin irritation or redness develops.

Section 50567-7

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.
Section 50570-1

Do not use on

  • broken skin
  • large areas of the skin
Section 51727-6

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)

Section 51945-4

Section 53413-1

Call 818-324-4339 or visit www.miraclecreambybella.com

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active Ingredient

Sulfur 10%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For Treatment of acne
Dosage and Administration (34068-7)

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

or as directed by a doctor.

  • 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.
Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Other information Store at 68°F- 77°F (20°C- 25°C).

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation or redness develops.

Section 50567-7 (50567-7)

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.
Section 50570-1 (50570-1)

Do not use on

  • broken skin
  • large areas of the skin
Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 818-324-4339 or visit www.miraclecreambybella.com

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Sulfur 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)