ARTHRITIS RELIEF- trolamine salicylate 10% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Good Sense

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Trolamine Salicylate - 10%                Topical Analgesic ​Uses ​temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. ​When using this product • use only as directed • avoid taking a bath or shower within 1 hour before or after applying • do not bandage tightly or use with a heating pad • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of the children . If product is swallowed, get medical help or contact a Poison Control Center right away

Authorization status:

OTC monograph not final

Summary of Product characteristics

ARTHRITIS RELIEF- TROLAMINE SALICYLATE 10% CREAM
GOOD SENSE
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT PURPOSE
Trolamine Salicylate - 10% Topical Analgesic
DIRECTIONS
Adults and children over 2 years: • Apply to affected area not more
than 4 times daily Children 2 years
or younger: ask a doctor.
USES
temporarily reliefs minor pain associated with • arthritis •
simple backache •muscle strains •
bruises • cramps
WARNINGS
FOR EXTERNAL USE ONLY
ALLERGY ALERT: if prone to allergic reaction from aspirin or
salicylates, consult a doctor before use.
WHEN USING THIS PRODUCT • use only as directed • avoid taking a
bath or shower within 1 hour before
or after applying • do not bandage tightly or use with a heating pad
• avoid contact with eyes or muscous
membranes • do not apply to wounds or damaged skin
STOP USE AND ASK A DOCTOR IF • condition worsens • symptoms
persist for more than 7 days or clear up
and occur again within a few days • redness is present •
irritation develops
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF THE CHILDREN. If product is swallowed, get
medical help or contact a Poison
Control Center right away
INACTIVE INGREDIENTS
Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben,
Mineral Oil, Potassium
Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water
QUESTIONS? 1-866-483-2846
ARTHRITIS RELIEF
trolamine salicylate 10% cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 8 0 4-78 2
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TRO LAMINE SALICYLATE (UNII: H8 O40 40 BHD) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
TROLAMINE SALICYLATE 10 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1