Label: MOTHER DIRT DAILY WITH SALICYLIC ACID- acne lotion
- NDC Code(s): 80646-100-01
- Packager: MBX Llc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Use
-
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.
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
-
Directions
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.
- Other Information
-
Inactive Ingredients
water, glycerin, ethyl linoleate, astrocaryum tucuma seed butter, glyceryl cocoate, jojoba esters, ethyl olivate, lactobacillus ferment, galactoarabinan, cellulose, glucomannan, glycolipids, lactobacillus, morinda citrifolia extract, chitosan, arginine, cocos nucifera (coconut) fruit extract, stellaria media (chickweed) extract, olea europaea (olive) leaf extract, bacillus ferment
- 0.91 fl oz package
-
INGREDIENTS AND APPEARANCE
MOTHER DIRT DAILY WITH SALICYLIC ACID
acne lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80646-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.501 g in 100 mL Inactive Ingredients Ingredient Name Strength MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5) ETHYL OLIVATE (UNII: KKJ108Y20W) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) GLYCERYL COCOATE (UNII: WVK1CT5994) GLYCERIN (UNII: PDC6A3C0OX) COCONUT (UNII: 3RT3536DHY) KONJAC MANNAN (UNII: 36W3E5TAMG) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) GALACTOARABINAN (UNII: SL4SX1O487) JOJOBA OIL (UNII: 724GKU717M) ARGININE (UNII: 94ZLA3W45F) WATER (UNII: 059QF0KO0R) POWDERED CELLULOSE (UNII: SMD1X3XO9M) STELLARIA MEDIA (UNII: 2H03479QVR) CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) (UNII: 82LKS4QV2Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80646-100-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/05/2020 08/01/2023 Labeler - MBX Llc (116939094)