Label: CARING MILL ACNE SPOT TREATMENT- sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71328-062-01, 71328-062-02 - Packager: Clixit, Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use:
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Warnings:
For external use only.
When using this product
• Do not use on broken skin or large areas of skin
• Apply only to areas with acne
• 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
• Stop use and ask a doctor if skin irritation occurs or gets worse
• Rinse right away with water if product gets in eyes -
Directions:
• Clean the skin thoroughly before using
• Apply a thin layer to entire affected area
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• If bothersome dryness of peeling occurs, reduce application to once a day or every other day - Other Ingredients:
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SPL UNCLASSIFIED SECTION
HELPS CLEAR BLEMISHES FAST
Benefits
• Reduces redness and swelling
• Controls oil production
• Allows skin to heal
• Unblocks clogged pores
• Prevents new breakouts
• Will not cause redness or irritation
Results may vary
Maximum sulfur 10% penetrates pores to control acne
Camphor instantly cools and calms inflamed skin
Salicylic acid unblocks pores and sheds dead skin cells for faster healing
NOT TESTED ON ANIMALS
Made in the USA
Manufactured for FSA Store Inc.
240 W 37th St. 6th Floor
New York, NY 10018
Customer Help Line:
(844) 425-4948 - Packaging
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INGREDIENTS AND APPEARANCE
CARING MILL ACNE SPOT TREATMENT
sulfur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71328-062 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 WATER (UNII: 059QF0KO0R) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ISOPROPYL ALCOHOL (UNII: ND2M416302) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SALICYLIC ACID (UNII: O414PZ4LPZ) EDETATE SODIUM (UNII: MP1J8420LU) TROLAMINE (UNII: 9O3K93S3TK) ZINC OXIDE (UNII: SOI2LOH54Z) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71328-062-02 1 in 1 BOX 06/21/2021 1 NDC:71328-062-01 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/21/2021 Labeler - Clixit, Llc (014971694)
