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 Ingredients

Contains 5% Bellis perennis 1X

Cotnains 5% Hypericum perforatum 2X

Contains 5% Ruta graveolens 1X

Contains 5% Rhus tox 4X

Inactive Ingredients

Carbomer

Ethyl Alcohol

Eucalyptus Oil

Purified Water

Sodium Hydroxide

Dosage & Administration

Directions

Adults & 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

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

Relieves joint and tendon pain and inflammation.

Warnings

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

Do Not Use

Do not use if 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.

PRINCIPAL DISPLAY PANEL

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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: 53499-6492
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 70 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X]  in 70 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X]  in 70 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	1 [hp_X]  in 70 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: 53499-6492-8	1 in 1 CARTON	09/03/2021
1		70 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		09/03/2021

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-6492)