JACK BLACK CLEARING SPOT TREATMENT- sulfur gel 
Jack Black LLC

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.

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Jack Black Acne Remedy Clearing Spot Treatment

Active Ingredients

Sulfur 10%

Purpose

Acne Treatment

Uses

Warnings

  For external use only

When using this product

  • 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 medication at a time.
  • avoid product contact with silver jewelry.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Do Not Use

  • On broken skin
  • on large areas of the skin

Directions

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glycerin, Caprylic/Capric Triglyceride, Acacia Senegal Gum, Magnesium Aluminum Silicate, Glyceryl Stearate,
PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Butylene Glycol, Decylene Glycol, Zinc PCA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Sodium PCA, Isohexadecane, Ganoderma Lucidum Extract, Sodium Hydroxide, Bisabolol, Ethylhexylglycerin, Polysorbate 80, Lysine, Propanediol, Aloe Barbadensis Leaf Juice, Tetrasodium Glutamate Diacetate, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, 10-Hydroxydecanoic Acid, Sebacic Acid, Magnesium Chloride, Potassium Chloride,
Sodium Chloride, 1,10-Decanediol, Zinc Chloride

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JACK BLACK CLEARING SPOT TREATMENT 
sulfur gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
ALOE (UNII: V5VD430YW9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DECYLENE GLYCOL (UNII: S57M60MI88)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LEVOMENOL (UNII: 24WE03BX2T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LYSINE (UNII: K3Z4F929H6)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
SEBACIC ACID (UNII: 97AN39ICTC)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
1,10-DECANEDIOL (UNII: 5I577UDK52)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66738-436-011 in 1 CARTON02/12/2021
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00602/12/2021
Labeler - Jack Black LLC (847024036)

Revised: 11/2022
Document Id: ec94bb45-f4fd-4c50-e053-2a95a90ac467
Set id: 10b6eccd-ecb0-4505-9e59-78f0ba03abcd
Version: 5
Effective Time: 20221103
 
Jack Black LLC