OTC Medication Information: Jack Black Overnight Repair Moisturizer

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.

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.

MOISTUC
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
BUTYLENE GLYCOL
PENTYLENE GLYCOL
GLYCERIN
CETOSTEARYL ALCOHOL
LACTIC ACID
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)
TRIBEHENIN PEG-20 ESTERS
GLYCOLIC ACID
PROPANEDIOL
SODIUM HYDROXIDE
PHENOXYETHANOL
MEDIUM-CHAIN TRIGLYCERIDES
MALIC ACID
MANDELIC ACID
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
CITRIC ACID ACETATE
TARTARIC ACID
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
FYTIC ACID
ASTRAGALUS PROPINQUUS ROOT
DIPROPYLENE GLYCOL
ETHYLHEXYLGLYCERIN
LEVOMENOL
CLEOME GYNANDRA WHOLE
LECITHIN, SOYBEAN
CURCUMA LONGA WHOLE
GREEN TEA LEAF
HYALURONATE SODIUM
DECYL GLUCOSIDE
ALOE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66738-437-01 1 TUBE in 1 CARTON contains a TUBE
1 59 mL in 1 TUBE This package is contained within the CARTON (66738-437-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 02/12/2021
Labeler — Jack Black LLC (847024036)

Revised: 08/2021 Jack Black LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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