![MUSCLE ICE (PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, MAGNESIA PHOSPHORICA) GEL [PEACEFUL MOUNTAIN, INC.]](https://medic.hrt.org//dailymed/images/a25fa6ee-3238-436d-80ae-17dcfc7bfa0c/MuscleIce ACTTUBE 07-07-11approvedforuse.jpg)
| NDC | 43846-0005-1 |
| Set ID | a25fa6ee-3238-436d-80ae-17dcfc7bfa0c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Peaceful Mountain, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- ACTIVE INGREDIENTS
- INDICATIONS
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WARNINGS
For external use only. Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DIRECTIONS
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INACTIVE INGREDIENTS
Aloe Vera, Camphor Essential Oil, Carbomer (Ultrez 21), Edetate Disodium, Ginger Essential Oil, Lavender Essential Oil, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, St. John's Wort Essential Oil, Vitamin E Oil
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUSCLE ICE
phytolacca decandra, symphytum officinale, bellis perennis, ledum palustre, ruta graveolens, magnesia phosphorica gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 1 [hp_X] in 1 g COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 3 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 6 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X] in 1 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 9 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMPHOR OIL (UNII: 75IZZ8Y727) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE SODIUM (UNII: MP1J8420LU) GINGER OIL (UNII: SAS9Z1SVUK) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYPERICUM OIL (UNII: OZU2FC70HY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0005-1 105 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/08/2013 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0005)
