FRONTMAN FADE- salicylic acid cream, augmented

FRONTMAN FADE by

Drug Labeling and Warnings

FRONTMAN FADE by is a Otc medication manufactured, distributed, or labeled by Wingman Cover LLC, Cosmetica Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne medication

Use

For the treatment of acne.

Warnings

For external use only.

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.
• If eye contact occurs, flush thoroughly with water.

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

Directions

• cleanse skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur in rare cases, 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 or peeling occurs, reduce application to once a day or every other day.

Other information

Store at room temperature.

Inactive ingredients

water (aqua / eau), isododecane, titanium dioxide (CI 77891), isohexadecane, polyglyceryl-3 diisostearate, butylene glycol, disteardimonium hectorite, peg-30 dipolyhydroxystearate, silica, iron oxides (CI 77492), vp/hexadecene copolymer, kaolin, propylene carbonate, magnesium sulfate, iron oxides (CI 77491), phenoxyethanol, ethylhexyl palmitate, triethoxycaprylylsilane, cyclodextrin, caprylyl glycol, menthoxypropanediol, iron oxides (CI 77499), glycerin, lactobacillus/lemon peel ferment extract, mentha viridis (spearmint) leaf extract, silica dimethyl silylate, sodium hyaluronate, hexylene glycol

Questions?

Call (213) 214-1242 or visit www.befrontman.com

SPL UNCLASSIFIED SECTION

Dist. by Frontman Inc., Brooklyn, NY 11201. Made in Canada.

PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC:

79638-587-01

FRONTMAN
FADE

Acne Fader with salicylic acid
0.33 Oz (10 ML)

PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC:

79638-588-01

FRONTMAN
FADE

Acne Fader with salicylic acid
0.33 Oz (10 ML)

PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC:

79638-589-01

FRONTMAN
FADE

Acne Fader with salicylic acid
0.33 Oz (10 ML)

PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC:

79638-590-01

FRONTMAN
FADE

Acne Fader with salicylic acid
0.33 Oz (10 ML)

INGREDIENTS AND APPEARANCE

FRONTMAN FADE 
salicylic acid cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79638-587
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
titanium dioxide (UNII: 15FIX9V2JP)
isohexadecane (UNII: 918X1OUF1E)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
butylene glycol (UNII: 3XUS85K0RA)
disteardimonium hectorite (UNII: X687XDK09L)
peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)
silicon dioxide (UNII: ETJ7Z6XBU4)
ferric oxide yellow (UNII: EX438O2MRT)
vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)
kaolin (UNII: 24H4NWX5CO)
propylene carbonate (UNII: 8D08K3S51E)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
ferric oxide red (UNII: 1K09F3G675)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexyl palmitate (UNII: 2865993309)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
ferrosoferric oxide (UNII: XM0M87F357)
glycerin (UNII: PDC6A3C0OX)
spearmint (UNII: J7I2T6IV1N)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79638-587-01	1 in 1 CARTON	12/01/2020
1		10 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	12/01/2020

FRONTMAN FADE 
salicylic acid cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79638-588
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
titanium dioxide (UNII: 15FIX9V2JP)
isohexadecane (UNII: 918X1OUF1E)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
butylene glycol (UNII: 3XUS85K0RA)
disteardimonium hectorite (UNII: X687XDK09L)
peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)
silicon dioxide (UNII: ETJ7Z6XBU4)
ferric oxide yellow (UNII: EX438O2MRT)
vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)
kaolin (UNII: 24H4NWX5CO)
propylene carbonate (UNII: 8D08K3S51E)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
ferric oxide red (UNII: 1K09F3G675)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexyl palmitate (UNII: 2865993309)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
ferrosoferric oxide (UNII: XM0M87F357)
glycerin (UNII: PDC6A3C0OX)
spearmint (UNII: J7I2T6IV1N)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79638-588-01	1 in 1 CARTON	12/01/2020
1		10 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	12/01/2020

FRONTMAN FADE 
salicylic acid cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79638-589
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
titanium dioxide (UNII: 15FIX9V2JP)
isohexadecane (UNII: 918X1OUF1E)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
butylene glycol (UNII: 3XUS85K0RA)
disteardimonium hectorite (UNII: X687XDK09L)
peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)
silicon dioxide (UNII: ETJ7Z6XBU4)
ferric oxide yellow (UNII: EX438O2MRT)
vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)
kaolin (UNII: 24H4NWX5CO)
propylene carbonate (UNII: 8D08K3S51E)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
ferric oxide red (UNII: 1K09F3G675)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexyl palmitate (UNII: 2865993309)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
ferrosoferric oxide (UNII: XM0M87F357)
glycerin (UNII: PDC6A3C0OX)
spearmint (UNII: J7I2T6IV1N)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79638-589-01	1 in 1 CARTON	12/01/2020
1		10 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	12/01/2020

FRONTMAN FADE 
salicylic acid cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79638-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
titanium dioxide (UNII: 15FIX9V2JP)
isohexadecane (UNII: 918X1OUF1E)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
butylene glycol (UNII: 3XUS85K0RA)
disteardimonium hectorite (UNII: X687XDK09L)
peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)
silicon dioxide (UNII: ETJ7Z6XBU4)
ferric oxide yellow (UNII: EX438O2MRT)
vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)
kaolin (UNII: 24H4NWX5CO)
propylene carbonate (UNII: 8D08K3S51E)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
ferric oxide red (UNII: 1K09F3G675)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexyl palmitate (UNII: 2865993309)
triethoxycaprylylsilane (UNII: LDC331P08E)
caprylyl glycol (UNII: 00YIU5438U)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
ferrosoferric oxide (UNII: XM0M87F357)
glycerin (UNII: PDC6A3C0OX)
spearmint (UNII: J7I2T6IV1N)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79638-590-01	1 in 1 CARTON	12/01/2020
1		10 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	12/01/2020

Labeler - Wingman Cover LLC (117559654)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetica Laboratories Inc		255080491	MANUFACTURE(79638-587, 79638-588, 79638-589, 79638-590)