Indications and uses
Temporarily protects and helps relieve minor skin irritation and itching due to eczema, poison oak, ivy, or sumac, rashes, insect bites .
Skin Therapy Calm
- Manufacturer
- Harmony Herbal
- Effective date
- 2021-10-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:30:57
Label at a glance#
ProductSkin Therapy Calm
Active ingredientOATMEAL
Label structure9 sections
Dosage and administration
Directions: Apply to affected skin 2-3 times daily.
Label contents#
Full prescribing information#
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 doctor if symptoms worsen, or do not improve after regular use of this product as directed. Avoid contact with eyes.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70597-117-15 | 2024-04-01 | C162847 | 48780-1 | f386c649-b52b-0266-e053-dadaa90a7c1a | Skin Therapy CALM |
| 70597-117-15 | 2023-01-30 | C162847 | 48780-1 | f386c649-b52b-0266-e053-dadaa90a7c1a | Skin Therapy CALM |
Products#
Every source-derived product name is available through these pages.
- Skin Therapy Calm
- Colloidal Oatmeal 1 %
- LONICERA JAPONICA WHOLE
- NIACINAMIDE
- ATRACTYLODES LANCEA ROOT OIL
- ALLANTOIN, (+)-
- C10-18 TRIGLYCERIDES
- CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
- CAPRYLYL GLYCOL
- CETOSTEARYL ALCOHOL
- CETEARYL GLUCOSIDE
- COPTIS CHINENSIS ROOT
- DICTAMNUS DASYCARPUS ROOT
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- GLYCERYL STEARATE SE
- HYSSOPUS OFFICINALIS FLOWERING TOP
- WATER
- LINOLEIC ACID
- OATMEAL
- ISOPROPYL PALMITATE
- SODIUM PYRROLIDONE CARBOXYLATE
- ALOE VERA LEAF
- OLIVE OIL
- PHELLODENDRON AMURENSE BARK
- PHENYLETHYL ALCOHOL
- SCUTELLARIA BAICALENSIS ROOT
- TOCOPHEROL
- PLATYCLADUS ORIENTALIS WHOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70597-117 | 70597-117-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 150f1de0-6a3d-5f3d-e063-6294a90a6457 | 50ecfbe1-503c-0d71-e054-00144ff8d46c | 2024-04-01 | Warnings | 50ecfbe1-503c-0d71-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.