ARNIFLORA - arnica montana gel 
Schwabe North America, 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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Arniflora

Active Ingredient

ARNICA MONTANA  1X 

Inactive Ingredient

carbomer

ethyl alcohol

purified water

sodium hydroxide

witch hazel distillate

Dosage and Administration

Directions

Apply thin layer to affected area. Massage gently or use compress.

For best results, use promptly after injury or trauma occurs

Adults and children 6 years of age and older: apply to affected area up to 4 times daily

Patch test recommened on sensitive skin

Indications & Usage

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Purpose

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Warnings

For external use only.

Avoid contact with eyes and broken skin.

Do not use

Do not use if hypersensitive to any ingredients in this product, in breast area when breast-feeding.

Stop Use

Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be signs of a serious condition.

Pregnant or breast feeding

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

Keep out of reach of children

Keep out of reach of children.

Overdose

If swallowed, seek medical help or contact a Poison Control Center right away.

LBN21825097_07_Arniflora_2_75oz_CTN_FNL.jpg

Add image transcription here...

ARNIFLORA  
arnica montana gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 28 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
WITCH HAZEL (UNII: 101I4J0U34)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5090-41 in 1 CARTON01/01/201105/31/2026
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:53499-5090-81 in 1 CARTON01/01/2011
278 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2011
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-5090)

Revised: 9/2023
Document Id: 5f98d2ef-264b-4585-a708-4d4e514f92e6
Set id: 935bf19d-a32c-49b8-a5cc-13e7ddfb23fe
Version: 13
Effective Time: 20230922
 
Schwabe North America, Inc