SPORTSCREME- trolamine salicylate cream

Sportscreme by

Drug Labeling and Warnings

Sportscreme by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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:O414PZ4LPZ)	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: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-7300-1	1 in 1 CARTON	01/01/1999
1		35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-7300-3	1 in 1 CARTON	01/01/1999
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-7300-4	1 in 1 CARTON	01/01/1999
3		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/01/1999

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	ANALYSIS(41167-7300) , LABEL(41167-7300) , MANUFACTURE(41167-7300) , PACK(41167-7300)