Pain Relieving Topical Analgesic: Package Insert and Label Information

PAIN RELIEVING TOPICAL ANALGESIC- trolamine salicylate cream
Top Care

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.

Active ingredient Purpose

Trolamine Salicylate — 10% Topical Analgesic

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.

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

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 • 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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
Cetyl Alcohol
Glycerin
Methylparaben
Mineral Oil
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
Propylparaben
Stearic Acid
TROLAMINE
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-884-03 1 TUBE in 1 CARTON contains a TUBE
1 89 g in 1 TUBE This package is contained within the CARTON (36800-884-03)
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 Operations
Product Quest Mfg 927768135 manufacture (36800-884), label (36800-884)

Revised: 06/2018 Top Care

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