SPORTS FOR TRAUMA GEL- bellis perennis, hypericum perfomatum,toxicodendron pubscens leaf, ruta graveolens flowering top gel
Schwabe Mexico, S.A. de C.V.

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.

----------

SPORTS GEL FOR TRAUMA

Active Ingredients

Bellis perennis 1X

Hypericum perforatum 2X

Rhus Toxicodendron (Toxicodendron pubescens) 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 & 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 toxicodendron) 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.

Overdose

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

21825492-Sports Gel_2.jpg

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68466-0002
Route of Administration	TOPICAL, TOPICAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68466-0002-8	1 in 1 CARTON	07/01/2004	01/31/2024
1		71 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2004	01/31/2024

Labeler - Schwabe Mexico, S.A. de C.V. (812805901)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(68466-0002)

Revised: 9/2021

Document Id: 5b224bcf-118c-4703-80c8-906c48ed5701

Set id: ffc7aa16-ff73-41fa-bb3b-c3fea62c893f

Version: 4

Effective Time: 20210903

Schwabe Mexico, S.A. de C.V.