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NDC 73300-0002-01 Muscles 30; 6; 12 [hp_C]/g; [hp_C]/g; [hp_C]/g Details

Muscles 30; 6; 12 [hp_C]/g; [hp_C]/g; [hp_C]/g

Muscles is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Spirit Homeopathy LLC. The primary component is ARNICA MONTANA WHOLE; HYPERICUM PERFORATUM WHOLE; RUTA GRAVEOLENS FLOWERING TOP.

Product Information

NDC	73300-0002
Product ID	73300-0002_284b0905-595d-4c4c-ad0b-410e4b5d8353
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Muscles
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hypericum Perforatum, Ruta Graveolens, Arnica Montana
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	30; 6; 12
Active Ingredient Units	[hp_C]/g; [hp_C]/g; [hp_C]/g
Substance Name	ARNICA MONTANA WHOLE; HYPERICUM PERFORATUM WHOLE; RUTA GRAVEOLENS FLOWERING TOP
Labeler Name	Spirit Homeopathy LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73300-0002-01 (73300000201)

Pricing Information	N/A
NDC Package Code	73300-0002-1
Billing NDC	73300000201
Package	228 g in 1 TUBE (73300-0002-1)
Marketing Start Date	2020-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b48b3045-a6e5-406e-a0af-7dc101f5792e Details

ACTIVE INGREDIENTS:

Hypericum Perforatum 6C, Ruta Graveolens 12C, Arnica Montana 30C.

INDICATIONS:

Relieve tension in injured or hard-working muscles, sore spots and bruises, slight swelling or discomfort. If you're uncomfortable, nourish your muscles with this stuff.

WARNINGS:

For external use only. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

You give it all you've got in your sport, but with this gel, show restraint! Apply liberally if you want, but not frequently. Three times daily should be your maximum, and if you need it daily for a week or more, be sure you're in touch with your physician. For training purposes, apply before intense training sessions once daily for up to 5 days or no more than twice in a week for regular use.

INDICATIONS:

Relieve tension in injured or hard-working muscles, sore spots and bruises, slight swelling or discomfort. If you're uncomfortable, nourish your muscles with this stuff.

INACTIVE INGREDIENTS:

Water, Aloe Vera Leaf Juice Extract, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide.

QUESTIONS:

Dist. By: Spirit Homeopathy LLC

13809 Research Blvd

Suite 500

Austin, TX 78750

PACKAGE LABEL DISPLAY:

Give yourself

10 TO 15

HOMEOPATHIC

[MUSCLES]

relief and prevention

INJURED • STIFF • SORE

TRAINING • DAILY • REHAB

NET WT 8 OZ (228 g)

INGREDIENTS AND APPEARANCE

MUSCLES

hypericum perforatum, ruta graveolens, arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73300-0002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	6 [hp_C] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_C] in 1 g
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	30 [hp_C] in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73300-0002-1	228 g in 1 TUBE; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/27/2020

Labeler - Spirit Homeopathy LLC (033844885)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(73300-0002) , api manufacture(73300-0002) , label(73300-0002) , pack(73300-0002)

Revised: 1/2022

Document Id: 284b0905-595d-4c4c-ad0b-410e4b5d8353

Set id: b48b3045-a6e5-406e-a0af-7dc101f5792e

Version: 2

Effective Time: 20220117

Search by Drug Name or NDC

NDC 73300-0002-01 Muscles 30; 6; 12 [hp_C]/g; [hp_C]/g; [hp_C]/g Details

Muscles 30; 6; 12 [hp_C]/g; [hp_C]/g; [hp_C]/g

Product Information

Package

Package Images

NDC 73300-0002-01 (73300000201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b48b3045-a6e5-406e-a0af-7dc101f5792e Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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