SPORTSCREME

Main information

  • Trade name:
  • SPORTSCREME- trolamine salicylate cream
  • Composition:
  • TROLAMINE SALICYLATE 10 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SPORTSCREME- trolamine salicylate cream
    United States
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 41167-7300-1, 41167-7300-3, 41167-7300-4
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SPORTSCREME- trolamine salicylate cream

Chattem, Inc.

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.

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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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 7-730 0

Route of Administration

TOPICAL

Chattem, Inc.

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

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO TASSIUM PHO SPHATE, UNSPECIFIED FO RM (UNII: B78 6 2WZ6 32)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 7-730 0 -3

1 in 1 CARTON

1

8 5 g in 1 TUBE

2

NDC:4116 7-730 0 -4

1 in 1 CARTON

2

113 g in 1 TUBE

3

NDC:4116 7-730 0 -1

1 in 1 CARTON

3

35 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 1/0 1/19 9 9

Labeler -

Chattem, Inc. (003336013)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cha tte m

Plant 2

8 30 410 721

ANALYSIS(4116 7-730 0 ) , LABEL(4116 7-730 0 ) , MANUFACTURE(4116 7-730 0 ) , PACK(4116 7-730 0 ) ,

RECOVERY(4116 7-730 0 ) , RELABEL(4116 7-730 0 ) , REPACK(4116 7-730 0 )

Revised: 1/2014