SPORTSCREME- trolamine salicylate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chattem, Inc.

INN (International Name):

TROLAMINE SALICYLATE

Composition:

TROLAMINE SALICYLATE 10 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical analgesic temporarily relieves minor pain associated with: - arthritis - simple backache - bursitis - tendonitis - muscle stains - muscle sprains - bruises - cramps

Authorization status:

OTC monograph not final

Summary of Product characteristics

SPORTSCREME- TROLAMINE SALICYLATE CREAM
CHATTEM, INC.
----------
SPORTSCREME
SPORTSCREME
DEEP PENETRATING PAIN RELIEVING RUB
_ACTIVE INGREDIENT_
Trolamine Salicylate 10%
_PURPOSE_
Topical analgesic
_USES_
temporarily relieves minor pain associated with:
arthritis
simple backache
bursitis
tendonitis
muscle stains
muscle sprains
bruises
cramps
_WARNINGS_
ALLERGY ALERT: Do not use if you are allergic to salicylates
(including aspirin) unless
directed by a doctor.
WHEN USING THIS PRODUCT
use only as directed
do not bandage tightly or use with a heating pad
avoid contact with the eyes or mucous 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 CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
ADULTS AND CHILDREN OVER 10 YEARS:
apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary no more than 4 times daily for temporary relief
INACTIVE INGREDIENTS
cetyl alcohol, FD&C blue no. 1, FD&C yellow 5, fragrance, glycerin,
methylparaben,
mineral oil, potassium phosphate, propylparaben, stearic acid,
triethanolamine, water
(229-121)
PRINCIPAL DISPLAY PANEL
Fast Pain Relief
No Unpleasant Odor
SPORTSCREME
Deep Penetrating Pain Relieving Rub
Trolamine Salicylate (10%)
Net wt 3 oz (85g)
®
SPORTSCREME
trolamine salicylate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:41167-7300
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID -
UNII:O414PZ 4LPZ )
TROLAMINE
SALICYLATE
10 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CETYL ALCOHOL (UNII: 936JST6JCN)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753