NDC | 43846-0064-1 |
Set ID | 11c7e949-5706-45d9-92cf-ca2f6ba9efff |
Category | HUMAN OTC DRUG LABEL |
Packager | Peaceful Mountain, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENTS:
- INDICATIONS:
-
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.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
-
INACTIVE INGREDIENTS:
Purified Water, Whey Protein Concentrate (Milk), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Sodium Hydroxide (Solution), Tocopherols (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Camphor Essential Oil (Wood), Ginger Essential Oil (Root), Lavender Essential Oil (Flower), St. John’s Wort Essential Oil (Aerial Parts)
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
MUSCLE ICE
phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, whey protein, magnesia phosphorica, silicea, menthol (crystals) gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0064 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 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 COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 1 g WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY 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) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 9 [hp_X] in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM HYDROXIDE (UNII: 55X04QC32I) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X) GINGER (UNII: C5529G5JPQ) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0064-1 57 g in 1 PACKAGE; Type 0: Not a Combination Product 10/17/2016 03/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/17/2016 03/23/2022 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0064) , api manufacture(43846-0064) , label(43846-0064) , pack(43846-0064)