OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS
ARNICA MONTANA HPUS (1X)
BACK TO NORMAL ARNICA CREAM (70992-101)
- Manufacturer
- BACK TO NORMAL, LLC | HealthSpecialty
- Effective date
- 2022-01-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:16:09
Label at a glance#
ProductBACK TO NORMAL ARNICA
Active ingredientARNICA MONTANA
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
PURPOSE
FOR HEADACHES, MUSCLES & JOINTS
INDICATIONS & USAGE SECTION
USES: FIGHTS MUSCLE & JOINT PAIN, INFLAMMATION AND HEADACHES.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: APPLY CREAM TO ENTIRE AREA OF PAIN LOCATION AND SURROUNDING
AREAS UNTIL ABSORBED INTO SKIN. MASSAGE INTO SKIN FOR BEST RESULT. USE AS NEEDED.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: WATER, ISOPROPYLE PALMITATE,GLYCERY STEARATE, PEG-100 STEARATE,
NIACINAMIDE (VITAMIN B3), CETEARYL ALCOHOL, POLYSORBATE 60, PROPYLENE GLYCOL, STEARYL
ALCOHOL, GLYCERIN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, LAVANDULA ANGUSTIFOLIA
(LAVENDER) FLOWER/LEAF/STEM, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, THYMUS VULGARIS
(THYME) FLOWER/LEAF EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF
EXTRACT, EUCALYPTUS GLOVULUS LEAF EXTRACT, ORIGANUM MAJORANA LEAF EXTRACT, ZINGIBER OFFICINALE
(GINGER) ROOT EXTRACT, JUNIPERUS COMMUNIS FRUIT EXTRACT, SANTALUM ALBUM (SANDALWOOD) EXTRACT,
SALVIA SCLAREA (CLARY) EXTRACT, JUNIPERUS PHOENICEA GUM EXTRACT, POTASSIUM LACTATE, PHENOXYETHANOL,
BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, HYDROXYPROPYL METHYLCELLULOSE, ACRYLATES/
C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, GLUCONOLACTONE, SODIUM BENZOATE, ALOE BARBADENSIS
LEAF JUICE
WARNINGS SECTION
WARNING: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, DAMAGED SKIN OR WOUNDS.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70992-101-52 | 2024-04-01 | C162847 | 48780-1 | 1030e365-005b-111a-e063-dadaa90a10e2 | BACK TO NORMAL ARNICA CREAM (70992-101) |
| 70992-101-52 | 2024-01-30 | C162847 | 48780-1 | 1030e365-005b-111a-e063-dadaa90a10e2 | BACK TO NORMAL ARNICA CREAM (70992-101) |
Products#
Every source-derived product name is available through these pages.
- BACK TO NORMAL ARNICA
- ARNICA MONTANA
- WATER
- ISOPROPYL PALMITATE
- GLYCERYL STEARATE SE
- PEG-100 STEARATE
- NIACINAMIDE
- CETOSTEARYL ALCOHOL
- POLYSORBATE 60
- PROPYLENE GLYCOL
- STEARYL ALCOHOL
- GLYCERIN
- CHAMOMILE
- LAVANDULA ANGUSTIFOLIA FLOWER
- ROSEMARY
- THYMUS VULGARIS LEAF
- ACHILLEA MILLEFOLIUM
- MENTHA PIPERITA LEAF
- EUCALYPTUS GLOBULUS LEAF
- ORIGANUM MAJORANA
- GINGER
- JUNIPER BERRY
- SANDALWOOD
- CLARY SAGE
- JUNIPERUS PHOENICEA RESIN
- POTASSIUM LACTATE
- PHENOXYETHANOL
- BENZOIC ACID
- ETHYLHEXYLGLYCERIN
- GLYCERETH-2 COCOATE
- HYPROMELLOSE, UNSPECIFIED
- CARBOMER COPOLYMER TYPE A
- GLUCONOLACTONE
- SODIUM BENZOATE
- ALOE VERA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70992-101 | 70992-101-12, 70992-101-52 |
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 |
|---|---|---|---|---|---|---|
| 150f6a73-83d8-8739-e063-6294a90a51b5 | ae9147a5-e586-47e7-9007-0f6800a27d95 | 2024-04-01 | Warnings | ae9147a5-e586-47e7-9007-0f6800a27d95 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.