ACNE TINTED SPOT TREATMENT- resorcinol, sulfur liquid

Acne Tinted Spot Treatment by

Drug Labeling and Warnings

Acne Tinted Spot Treatment by is a Otc medication manufactured, distributed, or labeled by GLYTONE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Resorcinol 2%

Sulfur 8%

Purpose

Acne Treatment

Use

For the treatment of acne.

• Dries and clears acne blemishes and allows skin to heal.
• Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
• Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

Warnings

For external use only.

When using this product

• apply only to areas with acne
• rinse right away with water if it gets in eyes
• 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

Keep out of reach of children

If swallowed, ge medical help or contact a Poison Control Center right away.

Do not use

on

• broken skin
• large areas of the skin

Directions

• Cleanse the skin thoroughly before applying this product.
• Cover the affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three 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.

Inactive Ingredients

WATER, PROPYLENE GLYCOL. ALCOHOL DENAT., POLYSORBATE 20, CAPRYLIC/CAPRIC TRIGLYCERIDE, MAGNESIUM ALUMINUM SILICATE, SODIUM STEAROYL, GLUTAMATE, CETEARYL ALCOHOL, GLYCERYL SEARATE, POLYSORBATE 60, CHLOROXYLENOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, PHENOXYETHANOL, POLYGLYCERYL-6 PALMITATE.SUCCINATE, XANTHAN GUM, IRON OXIDES, TITANIUM DIOXIDE

Principal Display Panel

GLYTONE

ACNE TINTED SPOT TREATMENT

ACNE THERAPY

2% RESORCINOL

8% SULFURE

30ML / 1 FL. OZ.

INGREDIENTS AND APPEARANCE

ACNE TINTED SPOT TREATMENT 
resorcinol, sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84262-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.08 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.02 mg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
IRON OXIDES (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FARNESOL (UNII: EB41QIU6JL)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-4 PALMITATE (UNII: J6LAJ6FC55)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84262-023-01	1 in 1 BOTTLE	03/01/2024
1		30 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	03/01/2024

Labeler - GLYTONE LLC (119226548)

Registrant - GLYTONE LLC (119226548)