NDC | 62795-7007-7 |
Set ID | 12f6cf2f-a924-42b1-9ca0-c360c7a59244 |
Category | HUMAN OTC DRUG LABEL |
Packager | MediNatura Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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INGREDIENTS
Arnica montana 1X 3.3%, Calendula officinalis 1X 2.51%, Echinacea 1X 0.75%, Aconitum napellus 1X 0.08%, Millefolium 2X 2.71%, Hamamelis virginiana 2X 2.26%, Chamomilla 2X 0.91%, Belladonna 2X 0.75%, Bellis perennis 2X 0.75%, Arnica montana 3X 2.51%, Ruta graveolens 4X 3%, Baptisia tinctoria 4X 0.75%, Symphytum officinale 4X 0.15%, Hypericum perforatum 6X 0.12%, Arnica montana 10X 0.12%, Natural Ingredients.
- INDICATIONS
- KEEP OUT OF REACH OF CHILDREN
- USES
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WARNINGS
For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a health professional should be consulted. In rare cases allergic skin reaction may develop. Do not use if known sensitivity to T-Relief or any of its ingredients exists. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask health professional before use.
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DIRECTIONS
Twist off cap and remove foil seal. Adults and children 4 and older: Apply generously to affected area 2 to 3 times daily or more often if necessary, as directed by your health professional. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. For children under 4, consult your health professional.
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INACTIVE INGREDIENT
Organic Aloe Oil, (Organic Aloe Vera Powder, Organic Soybean Oil, Vitamin E) Caprylic/Capric Triglycerides (from Cocos nucifera), Carrageenan (processed Eucheuma seaweed) Organic Coconut Oil, Organic Ethanol, Organic Safflower Oil, Phenoxyethanol,(Preservative), Purified Water, Organic Shea Butter, Sodium Polyacrylate ( Emulsifier), Sunflower Seed Wax.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
T-RELIEF EXTRA STRENGTH CREAM
arnica montana, calendula officinalis flowering top, echinacea unspecified, aconitum napellus, achillea millefolium, hamamelis virginiana root bark stem bark, matricaria chamomilla, atropa belladonna, bellis perennis, ruta graveolens flowering top, baptisia tinctoria root, comfrey root and hypericum perforatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-7007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 1 g CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 1 [hp_X] in 1 g ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 1 [hp_X] in 1 g ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 2 [hp_X] in 1 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X] in 1 g MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 2 [hp_X] in 1 g ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 2 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 2 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 4 [hp_X] in 1 g BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 4 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 4 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) ALOE (UNII: V5VD430YW9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALCOHOL (UNII: 3K9958V90M) SAFFLOWER OIL (UNII: 65UEH262IS) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARRAGEENAN (UNII: 5C69YCD2YJ) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-7007-7 1 in 1 CARTON 10/19/2017 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/19/2017 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories 002290302 manufacture(62795-7007)