PEACE OUT ACNE HERO ROUTINE- salicylic acid kit

Peace Out Acne Hero Routine by

Drug Labeling and Warnings

Peace Out Acne Hero Routine by is a Otc medication manufactured, distributed, or labeled by Peace Out Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Patch: Salicylic Acid 0.5%

Serum: Salicylic Acid 2%

Purpose

Acne Treatment

Uses

• For the treatment of acne

Other

• Store between 15C - 30C

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 one medication should be used.
• Do not use if you are allergic to the dressing or any of its components.

Keep Out of Reach of Children.

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

Directions

Patch:

For products applied to and left on the skin:

• Cleanse thoroughly before applying this product
• Cover the entire affected area with one dot
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times a daily if needed or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or even every other day
• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Serum:

For products applied to and left on the skin:

• Clean the 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, 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
• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Patch:

Aloe Barbadensis (Aloe Vera) Leaf Extract, Retinyl Acetate
Patch: Hydrocolloid Polymer Technology

Serum:

Water/Aqua/Eau, Propanediol, Triheptanoin, Coco-Caprylate/Caprate, Niacinamide, Salicylic Acid, Isopentyldiol, Sodium Polyacryloyldimethyl Taurate, Zinc PCA, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Aloe Barbadensis Leaf, Trifolium Pratense (Clover) Flower Extract, Centella Asiatica Flower/Leaf/Stem Extract, Potassium Azeloyl Diglycinate, Saccharide Isomerate, Cetearyl Olivate, Glycerin, Sorbitan Olivate, Dilinoleic Acid/Butanediol Copolymer, Decyl Glucoside, Caprylyl Glycol, Trisodium Ethylenediamine Disuccinate, Castor Oil/IPDI Copolymer, Phenoxyethanol, Tocopheryl Acetate, Sodium Hydroxide, Ethylhexylglycerin

Questions or comments?

Call toll free 1-800-268-1962 M-F 9AM to 6PM PST

Company Information

Distributed by: Peace Out Inc. San Francisco, CA 94103 USA

Packaging

INGREDIENTS AND APPEARANCE

PEACE OUT ACNE HERO ROUTINE 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71494-005

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71494-005-01	1 in 1 CARTON; Type 0: Not a Combination Product	10/10/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL
Part 2	1 CONTAINER	10
Part 3	1 BOTTLE	10 mL

Part 1 of 3

PEACE OUT REPAIRING MOISTURIZER 
moisturizing

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	TRIHEPTANOIN (UNII: 2P6O7CFW5K)
INGR	TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
INGR	DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BAKUCHIOL (UNII: OT12HJU3AR)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	CETEARYL OLIVATE (UNII: 58B69Q84JO)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	CERAMIDE AP (UNII: F1X8L2B00J)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
INGR	COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
INGR	SORBITAN OLIVATE (UNII: MDL271E3GR)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
INGR	ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
INGR	LAUROYL LYSINE (UNII: 113171Q70B)
INGR	SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	COCONUT ALKANES (UNII: 1E5KJY107T)
INGR	DIACRONEMA LUTHERI (UNII: 5N7X0S4J0B)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	CERAMIDE 1 (UNII: 5THT33P7X7)
INGR	CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 2 of 3

PEACE OUT ACNE 
salicylic acid patch

Product Information
Item Code (Source)	NDC: 71494-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.359 mg

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	10/10/2022

Part 3 of 3

PEACE OUT ACNE SERUM 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 71494-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ZINC PIDOLATE (UNII: C32PQ86DH4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
GLYCERIN (UNII: PDC6A3C0OX)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
PROPANEDIOL (UNII: 5965N8W85T)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	10/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	10/10/2022

Labeler - Peace Out Inc. (043143413)