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

Sports For Trauma by

Drug Labeling and Warnings

Sports For Trauma by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Bellis perennis 1X

Hypericum perforatum 2X

Rhus Tox 3X

Ruta graveolens 1X

INACTIVE INGREDIENT

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 & USAGE

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.

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes or broken skin.

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 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

Children:

Keep out of reach of children.

ASK DOCTOR

Ask the Doctor:

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.

OVERDOSAGE

Overdosage:

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

PURPOSE

Purpose:

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

Relieves joint and tendon pain and inflammation.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 71 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X]  in 71 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	3 [hp_X]  in 71 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	1 [hp_X]  in 71 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5492-8	1 in 1 CARTON	07/01/2004
1		71 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2004

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-5492)