Jack Black Acne Remedy Overnight Repair Moisturizer

Jack Black Overnight Repair Moisturizer by

Drug Labeling and Warnings

Jack Black Overnight Repair Moisturizer by is a Otc medication manufactured, distributed, or labeled by Jack Black LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JACK BLACK OVERNIGHT REPAIR MOISTURIZER- salicylic acid lotion 
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 Overnight Repair Moisturizer

Active Ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• For the treatment of acne
• Clears acne blemishes and blackheads and allows skin to heal
• Helps keep skin clear of new acne blemishes and blackheads

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 medication at a time.

Keep out of reach of children.

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

Directions

• Clean the skin thoroughtly before applying this product
• cover the entire area with a thin layer once nightly
• if bothersome dryness or peeling occurs, reduce application to 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

Water, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Cetearyl Alcohol, Lactic Acid, Polyacrylate
Crosspolymer-6, Tribehenin PEG-20 Esters, Glycolic Acid, 1,3-propanediol, Sodium Hydroxide, Phenoxyethanol.
Caprylic/Capric Triglyceride, Malic Acid, Mandelic Acid, Polysilicone-11, Citric Acid, Tartaric Acid, Carbomer, Phytic Acid, Astragalus Membranaceus Root Extract, Dipropylene Glycol, Ethylhexylglycerin, Bisabolol, Cleome Gynandra Leaf Extract, Lecithin, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Decyl Glucoside, Aloe Barbadensis Leaf Juice.

JACK BLACK OVERNIGHT REPAIR MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-437
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LACTIC ACID (UNII: 33X04XA5AT)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
GLYCOLIC ACID (UNII: 0WT12SX38S)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MALIC ACID (UNII: 817L1N4CKP)
MANDELIC ACID (UNII: NH496X0UJX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
TARTARIC ACID (UNII: W4888I119H)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FYTIC ACID (UNII: 7IGF0S7R8I)
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LEVOMENOL (UNII: 24WE03BX2T)
CLEOME GYNANDRA WHOLE (UNII: IK61O1GX6H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-437-01	1 in 1 CARTON	02/12/2021
1		59 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	M006	02/12/2021

Labeler - Jack Black LLC (847024036)

Revised: 11/2022

Document Id: ec94bb45-f509-4c50-e053-2a95a90ac467

34390-5

Set id: 01d0911f-9e2b-4079-bcd0-0ebef9364fa6

Version: 8

Effective Time: 20221103