TROLAMINE SALICYLATE cream

Trolamine Salicylate by

Drug Labeling and Warnings

Trolamine Salicylate by is a Otc medication manufactured, distributed, or labeled by Perrigo New York Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises

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
• 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. (1-800-222-1222)

Directions

adults and children over 12 years:

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, stearic acid, triethanolamine, water

Questions or comments?

1-800-719-9260

Principal Display Panel

Temporary Minor Arthritis, Joint and Muscle Pain Relief

Odor Free Therapy

Compare to Aspercreme® active ingredient

Trolamine Salicylate 10%

Pain Relieving Cream

with Aloe

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

TROLAMINE SALICYLATE 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45802-356
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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: 45802-356-53	1 in 1 CARTON	11/26/2010
1		85 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	11/26/2010

Labeler - Perrigo New York Inc (078846912)