SLMD Soothe by Skin Ps Brands SLMD Body Seal

SLMD Soothe by

Drug Labeling and Warnings

SLMD Soothe by is a Otc medication manufactured, distributed, or labeled by Skin Ps Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLMD SOOTHE- oatmeal stick 
Skin Ps Brands

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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SLMD Body Seal

Active Ingredient

Colloidal Oatmeal 2.0%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to

• eczema
• rashes

Warnings

For External Use Only

When using this product

Avoid contact with eyes

Stop Use and ask a doctor if

• Condition worsens
• symptom last more than 7 days or clear up and occur again within a few days

Keep Out of reach of children

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

Directions

Apply directly to affected areas of skin

Other Information

  Store in a cool, dry place

Inactive Ingredients

Dimethicone,Water, Dimethicone, Butylene Glycol, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Niacinamide, Oryza Sativa (Rice) Bran Oil, Avena Sativa (Oat) Kernel Flour, Potassium Cetyl Phosphate, 1,2-Hexandiol, Caprylyl Glycol, Aluminum Starch Octenylsuccinate, Carbomer, Vitis Vinifera (Grape) Seed Oil, Hydrogenated Palm Glycerides, Aminomethyl Propanol, Sodium PCA, Hordeum Distichon (Barley) Extract, Panthenol, Tocopheryl Acetate, Phellodendron Amurense Bark Extract, Santalum Album (Sandalwood) Extract, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Dipotassium Glycyrrhizate, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea ) Butter, Pentylene Glycol, Squalane, Ceramide NP, Sodium Hyaluronate.

SLMD SOOTHE 
oatmeal stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73318-4190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CASTOR OIL (UNII: D5340Y2I9G)
LAURYL LAURATE (UNII: GPW77G0937)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
STARCH, RICE (UNII: 4DGK8B7I3S)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OAT KERNEL OIL (UNII: 3UVP41R77R)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ceramide NP (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
OLEIC ACID (UNII: 2UMI9U37CP)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
OAT (UNII: Z6J799EAJK)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73318-4190-2	1 in 1 CARTON	08/25/2020
1	NDC: 73318-4190-1	15 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/25/2020	03/31/2022

Labeler - Skin Ps Brands (081085221)

Revised: 6/2022

Document Id: 509d2bbe-ffea-4a0d-824e-7f927fa60f5b

34390-5

Set id: 13a625c0-18fd-4623-8197-06d4b93a5dd5

Version: 3

Effective Time: 20220607