ANNA GUANCHE MD MIRACLE CREAM THE PIMPLE CREAM- sulfur cream

Anna Guanche MD Miracle Cream The Pimple Cream by

Drug Labeling and Warnings

Anna Guanche MD Miracle Cream The Pimple Cream by is a Otc medication manufactured, distributed, or labeled by Bella Cosmeceuticals, Inc., KDC/ONE SOCAL LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sulfur 10%

PURPOSE

Purpose

Acne Treatment

WARNINGS

For external use only.

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.

STOP USE

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

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

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.

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)

DO NOT USE

Do not use on

• broken skin
• large areas of the skin

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANNA GUANCHE MD MIRACLE CREAM THE PIMPLE CREAM 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80841-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
GLYCERIN (UNII: PDC6A3C0OX)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80841-100-01	29.5 mL in 1 JAR; Type 0: Not a Combination Product	11/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/17/2020

Labeler - Bella Cosmeceuticals, Inc. (117691855)

Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE SOCAL LABORATORIES, LLC		118384240	manufacture(80841-100)