Trauma Cream
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2013-08-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:21
Label at a glance#
ProductTrauma Cream
Active ingredientCalcium Sulfide, Hypericum Perforatum, Phosphorus, Aconitum Napellus, Arnica Montana, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Colchicum Autumnale Bulb, Ledum Palustre Twig, Achillea Millefolium, Toxicodendron Pubescens Leaf, Apis Mellifera, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Goldenseal, Ruta Graveolens Flowering Top, Comfrey Root
Label structure10 sections
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Trauma Cream: Formulated for symptoms associated with injury, trauma or surgery such as pain, stiffness, swelling, bruising and inflammation.
DOSAGE & ADMINISTRATION SECTION
Directions: EXTERNAL USE ONLY. Ages 2 and up, apply a thin coating up to four times daily to affected area. Repeat as needed or as directed by your healthcare professional. Under age 2, consult a licensed healthcare professional. Avoid eye contact; if eye contact occurs, rinse with water for at least 15 minutes. If allergic response or irritation occurs or persists, discontinue use and consult a licensed healthcare professional.
OTC - ACTIVE INGREDIENT SECTION
Hepar sulph. calc. 10x, Hypericum 10x, Phosphorus 10x, Aconitum nap. 8x, Arnica 8x, Belladonna 8x, Bellis 8x, Calendula 8x, Colchicum 8x, Ledum 8x, Millefolium 8x, Rhus toxicodendron 8x, Apis mel. 3x, Arnica 3x, Calendula 3x, Chamomilla 3x, Echinacea 3x, Hamamelis 3x, Hydrastis 3x, Hypericum 3x, Ruta 3x, Symphytum 3x.
OTC - PURPOSE SECTION
Formulated for symptoms associated with injury, trauma or surgery such as pain, stiffness, swelling, bruising and inflammation.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water, Pomace Olive Oil, El Deodorized Cocoa Butter, Beeswax (organic), Jojoba Esters, Soy Lecithin (organic), USP Glycerin, natural (organic, vegetable), USP Gluten-free, non-GMO Cane Alcohol (organic), Grapefruit Seed Extract, Plant preservatives (natural), Gluten-free, non-GMO Xanthan Gum.
OTC - QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2001-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a28b-f424-e053-dadaa90a57ce | Trauma Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2001-4 | Trauma Cream | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2001 | TRAUMA CREAM (HEPAR SULPH. CALC., HYPERICUM, PHOSPHORUS, ACONITUM NAP., ARNICA, BELLADONNA, BELLIS, CALENDULA, COLCHICUM, LEDUM, MILLEFOLIUM, RHUS TOXICODENDRON, APIS MEL., CHAMOMILLA, ECHINACEA, HAMAMELIS, HYDRASTIS, RUTA, SYMPHYTUM) CREAM [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 1 package rows | 20131227_64a12947-c8c6-ff96-6816-ad0bfdbda054.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Achillea Millefolium | ACTIVE INGREDIENT | 2FXJ6SW4PK | 1 | |
| Aconitum Napellus | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| Apis Mellifera | ACTIVE INGREDIENT | 7S82P3R43Z | 1 | |
| Arnica Montana | ACTIVE INGREDIENT | O80TY208ZW | 1 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| Bellis Perennis | ACTIVE INGREDIENT | 2HU33I03UY | 1 | |
| Calcium Sulfide | ACTIVE INGREDIENT | 1MBW07J51Q | 1 | |
| Calendula Officinalis Flowering Top | ACTIVE INGREDIENT | 18E7415PXQ | 1 | |
| Colchicum Autumnale Bulb | ACTIVE INGREDIENT | 993QHL78E6 | 1 | |
| Comfrey Root | ACTIVE INGREDIENT | M9VVZ08EKQ | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE INGREDIENT | T7S323PKJS | 1 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| Ledum Palustre Twig | ACTIVE INGREDIENT | 877L01IZ0P | 1 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 1 | |
| Ruta Graveolens Flowering Top | ACTIVE INGREDIENT | N94C2U587S | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 1 | |
| Achillea Millefolium | ACTIVE MOIETY | 2FXJ6SW4PK | 1 | |
| Aconitum Napellus | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| Apis Mellifera | ACTIVE MOIETY | 7S82P3R43Z | 1 | |
| Arnica Montana | ACTIVE MOIETY | O80TY208ZW | 1 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| Bellis Perennis | ACTIVE MOIETY | 2HU33I03UY | 1 | |
| Calcium Sulfide | ACTIVE MOIETY | 1MBW07J51Q | 1 | |
| Calendula Officinalis Flowering Top | ACTIVE MOIETY | 18E7415PXQ | 1 | |
| Colchicum Autumnale Bulb | ACTIVE MOIETY | 993QHL78E6 | 1 | |
| Comfrey Root | ACTIVE MOIETY | M9VVZ08EKQ | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 1 | |
| Hamamelis Virginiana Root Bark/stem Bark | ACTIVE MOIETY | T7S323PKJS | 1 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| Ledum Palustre Twig | ACTIVE MOIETY | 877L01IZ0P | 1 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 1 | |
| Ruta Graveolens Flowering Top | ACTIVE MOIETY | N94C2U587S | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| Citrus Paradisi Seed | INACTIVE INGREDIENT | 12F08874Y7 | 1 | |
| Cocoa Butter | INACTIVE INGREDIENT | 512OYT1CRR | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Jojoba Oil | INACTIVE INGREDIENT | 724GKU717M | 1 | |
| Lecithin, Soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| Lonicera Japonica Flower | INACTIVE INGREDIENT | 4465L2WS4Y | 1 | |
| Olive Oil | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| Royal Jelly | INACTIVE INGREDIENT | L497I37F0C | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Trauma Cream
- Hepar sulph. calc., Hypericum, Phosphorus, Aconitum nap., Arnica, Belladonna, Bellis, Calendula, Colchicum, Ledum, Millefolium, Rhus toxicodendron, Apis mel., Chamomilla, Echinacea, Hamamelis, Hydrastis, Ruta, Symphytum
- Calcium Sulfide
- Hypericum Perforatum
- Phosphorus
- Aconitum Napellus
- Arnica Montana
- Atropa Belladonna
- Bellis Perennis
- Calendula Officinalis Flowering Top
- Colchicum Autumnale Bulb
- Ledum Palustre Twig
- Achillea Millefolium
- Toxicodendron Pubescens Leaf
- Apis Mellifera
- Matricaria Recutita
- Echinacea, Unspecified
- Hamamelis Virginiana Root Bark/stem Bark
- Goldenseal
- Ruta Graveolens Flowering Top
- Comfrey Root
- Water
- Olive Oil
- Cocoa Butter
- Royal Jelly
- Jojoba Oil
- Lecithin, Soybean
- Glycerin
- Alcohol
- Citrus Paradisi Seed
- Lonicera Japonica Flower
- Xanthan Gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2001 | 55714-2001-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Cocoa Butter | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Lecithin, Soybean | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg |
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 |
|---|---|---|---|---|---|---|
| 9146c189-b164-3d6e-5e36-60e30677db72 | 64a12947-c8c6-ff96-6816-ad0bfdbda054 | 2013-08-01 | Warnings | 9146c189-b164-3d6e-5e36-60e30677db72 64a12947-c8c6-ff96-6816-ad0bfdbda054 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.