SPORTS FOR TRAUMA- bellis perennis, hypericum perfomatum,toxicodendron pubscens leaf, ruta graveolens flowering top 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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SPORTS GEL FOR TRAUMA

Active Ingredients

Bellis perennis 1X

Hypericum perforatum 2X

Rhus Tox 3X

Ruta graveolens 1X

Inactive Ingredients

Ethyl Alcohol

Eucalyptus Oil

Carbomer

Purified Water

Sodium Hydroxide

Dosage & Administration

Dosage:

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

Rub in gently.

Children under 6 years of age:Consult a doctor.

Patch test recommended on sensitive skin.

Indications and Usage

Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with over exertion, sprains, falls, blows and minor sports injuries.

Relieves joint and tendon pain and inflammation.

Purpose

Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with over exertion, sprains, falls, blows and minor sports injuries.
Relieves joint and tendon pain and inflammation.

Warning

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

Do Not Use

Do not use if you are hypersensitive to poison ivy (Rhus tox) or any other ingredients in this product.
Breast-feeding women should not apply to breast area.

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 then occur again within a few days.
These could be signs of a serious condition.

Pregnancy 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 immediately.

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SPORTS FOR TRAUMA 
bellis perennis, hypericum perfomatum,toxicodendron pubscens leaf, ruta graveolens flowering top gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5492
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 71 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]  in 71 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF3 [hp_X]  in 71 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP1 [hp_X]  in 71 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5492-81 in 1 CARTON07/01/200401/31/2024
171 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/200401/31/2024
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-5492)

Revised: 9/2021
 
Schwabe North America, Inc