SKIN THERAPY CALM- colloidal oatmeal 1 % cream 
Harmony Herbal

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Harmony Herbal (as PLD) - Skin Therapy CALM (70597-117) - DELIST

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

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

eczema, poison oak, ivy, or sumac, rashes, insect bites .

Warnings


For external use only.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions:Apply to affected skin 2-3 times daily.

Inactive ingredients

Inactive ingredients:Water, Organic Aloe Barbadensis Leaf Juice, Thuja Orientalis Extract, Scutellaria Baicalensis Root Extract, Phellodendron Amurense Bark Extract, Coptis Chinesis Root Extract, Hyssopus Officinalis Extract, Atractylodes Lancea Root Extract, Lonicera Japonica Stem Extract, Dictamnus Desycarpus Root Extract, Organic Olea Europaea (Olive) Oil, Glycerin (plant derived), Cetearyl Alcohol, Cetearyl Glucoside, Caprylic Capric Triglycerides , Glyceryl Stearate (plant derived), Isopropyl Palmitate (plant derived), Niacinamide, Phenethyl Alcohol, Caprylyl Glycol, Ethylhexyl Glycerin, C10-18 Triglycerides, Allantoin, Sodium PCA , Linoleic Acid, Tocopherol.

Stop use and ask a doctor if...

Stop use and ask a doctorif symptoms worsen, or do not improve after regular use of this product as directed. Avoid contact with eyes.

Box

Tube

SKIN THERAPY CALM 
colloidal oatmeal 1 % cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70597-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ATRACTYLODES LANCEA ROOT OIL (UNII: EC228KGY00)  
ALLANTOIN, (+)- (UNII: XDK458E1J9)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)  
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
WATER (UNII: 059QF0KO0R)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PLATYCLADUS ORIENTALIS WHOLE (UNII: 835370K47L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70597-117-151 in 1 BOX06/01/201712/31/2023
142.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01606/01/201712/31/2023
Labeler - Harmony Herbal (071401048)

Revised: 4/2024
Document Id: 150f1de0-6a3d-5f3d-e063-6294a90a6457
Set id: 50ecfbe1-503c-0d71-e054-00144ff8d46c
Version: 4
Effective Time: 20240401
 
Harmony Herbal