ARTHRO PHARMA PAIN RELIEF (camphor- synthetic gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)

Available from:

Jajy Ventures, LLC

INN (International Name):

CAMPHOR - UNII:5TJD82A1ET)

Composition:

CAMPHOR (SYNTHETIC) 30 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.  

Authorization status:

OTC monograph not final

Summary of Product characteristics

ARTHRO PHARMA PAIN RELIEF- CAMPHOR (SYNTHETIC) GEL
JAJY VENTURES, LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
ARTHRO PHARMA PAIN RELIEF GEL
_DRUG FACTS_
ACTIVE INGREDIENT:
Camphor 3.00%
Topical Analgesic
INDICATIONS:
For the temporary relief of minor aches and pains of the muscles and
joints associated with arthritis,
simple backache, sprains, bruises and strains.
WARNINGS:
For external use only.
Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and
consult physician.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, consult physician.
Do not apply to wounds or damaged skin.
Do not bandage tightly.
IF PREGNANT OR BREAST FEEDING,
contact physician prior to use.
DIRECTIONS:
Adults and children two-years of age or older: Apply to affected area
not more than three to four times
daily. Children under two-years of age: consult a physician.
ADDITIONAL INFORMATION:
Store at room temperature.
OTHER INGREDIENTS:
Aqua (Deionized Water), Carbomer, Centerlla Asiatica (Gotu Kola)
Extract, Cinnamomum Zeylanicum
(Cinnamon) Bark Extract, Ethylhexylglycerin, Gaultheria Procumbens
(Teaberry) Extract,
Harpagophytum Procumbens (Devil's Claw) Extract, Helichrysum Italicum
Extract, Hypericum
Perfortum (St. John's Wort) Extract, Maltodextrin, Phenoxyethanol,
Polysorbate-20, SD-Alcohol,
Sodium Hydroxide.
PACKAGE LABELING:
Jajy Ventures, LLC
ARTHRO PHARMA PAIN RELIEF
camphor (synthetic) gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:710 46 -0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD8 2A1ET)
CAMPHOR
(SYNTHETIC)
30 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)
CENTELLA ASIAT