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.

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SPORTS GEL FOR TRAUMA

Active Ingredients

Contains 5% Bellis perennis 1X

Contains 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 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.

Overdose

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

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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:68466-1002
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 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

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
Packaging
1	NDC:68466-1002-8	1 in 1 CARTON	09/03/2021
1		70 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		09/03/2021

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(68466-1002)

Revised: 10/2022

Document Id: 03af4aad-6a11-42e1-89ab-e4b693dce080

Set id: 002745e8-6f11-4b47-99d3-dddef0c170d6

Version: 2

Effective Time: 20221012

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