PAIN RELIEVING TOPICAL ANALGESIC- trolamine salicylate 10% 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.

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Drug Facts

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-884
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-884-031 in 1 CARTON08/18/2014
189 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/18/2014
Labeler - Top Care (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-884) , label(36800-884)

Revised: 6/2018
Document Id: 32912d46-af6d-4597-8713-48f3cd066a07
Set id: dd95db29-0be7-4b46-8631-62b58bd267c2
Version: 1
Effective Time: 20180626
 
Top Care