ARNICA GEL- arnica montana gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)
Available from:
King Bio Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses Temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested. Drug Facts ____________________________________________________________________________________________________________________ Active ingredients                                   Purpose† Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion. *HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.
Authorization status:
unapproved homeopathic
Authorization number:
57955-3203-3

ARNICA GEL- arnica montana gel

King Bio Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Arnica Gel

Drug

Facts __________________________________________________________________________________________________________

Active ingredient:

Arnica montana 1X HPUS*-7%

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due

to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been

evaluated by the FDA. Product has not been clinically tested.

Warnings :

For external use only. Avoid contact with eyes and broken skin.

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

Nursing mothers should not apply to breast area.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Stop use and ask a doctor if: symptoms worsen or do not improve within 3 days skin irritation,

redness or rash occurs.

Keep out of reach of children.

Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply

at the onset of symptoms.

Other information:

Do not use if carton or tube seal is broken.

Store at 68-77°F (20-25°C).

Keep carton for complete drug facts and product information.

Inactive ingredients: Alcohol denat, carbomer, purified water, sodium hydroxide.

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients Purpose†

Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising

due to minor injuries or overexertion.

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

ARNICA GEL

arnica montana gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:579 55-320 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

1 [hp_X] in 73 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

King Bio Inc.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:579 55-320 3-3

1 in 1 CARTON

1

73 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/0 7/20 16

Labeler -

King Bio Inc. (617901350)

Registrant -

King Bio Inc. (617901350)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

King Bio Inc.

6 179 0 1350

ma nufa c ture (579 55-320 3)

Revised: 3/2016

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