PAIN RELIEVING TOPICAL ANALGESIC- trolamine salicylate 10% cream

Pain Relieving Topical Analgesic by

Drug Labeling and Warnings

Pain Relieving Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                               Purpose

Trolamine Salicylate - 10%                Topical Analgesic

DOSAGE & ADMINISTRATION

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 no more than 4 times daily Children 12 years or younger: ask a doctor.

PURPOSE

INDICATIONS & USAGE

​Uses ​temporarily reliefs minor pain associated with arthritis simple backache muscle strains bruises cramps

WarningsFor 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVING TOPICAL ANALGESIC 
trolamine salicylate 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-884
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)
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: 36800-884-03	1 in 1 CARTON	08/18/2014
1		89 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	08/18/2014

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-884) , label(36800-884)