ANALGESIC CREME RUB- trolamine salicylate 10% cream 
Major Pharmaceuticals

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 Fact

Active ingredient

Trolamine Salicylate 10%

Purpose

Topical Analgesic

Uses

for the temporary relief of aches and pains of mucles and joints due to

arthritis
simple backache
bruises
sprains
strains

Warnings

For external use only

Allergy Alert : Do not use if you are allergic to saliclates ( including aspirin )unless directed by a doctor.

use only as directed
avoid contact with the eyes and mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
do not use with heating pad or other heasting devices
do not apply to irritated skin

Stop use and ask a doctor if

condition worses
systoms persist for more than 7 days or clear up and occurs again within a few days
if redness to present
irritation develops

If pregnant or breast feeding , ask a health professional before use.

Keep out of the reach of children


If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age an older;

Apply generously to affected area not more than 3 to 4 times daily. Massage into painful area until thoroughly absorbed into the skin. Repeat as nessary but not more than 4 times daily.

Children under 12 years of age : consult a doctor.

Inactive ingredients

aloe barbadensis leaf juice ( aloe vera), cetyl alcohol, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, stearic acid, triethanolamine, water

Principal Display Panel - Tube 3.0 oz

Major                                              NDC 0904-5857-56

Trolamine Salicylate 10%

Analgesic Creme Rub with aloe        

                                                    Net Weight 3 oz ( 85g )

Principal Display Panel - Tube 3.0 oz

Principal Display Panel - Carton 3.0 oz

Major                                                              NDC 0904-5857-56

Trolamine Salicylate 10%

Analgesic Creme Rub with aloe

                                                                      Net Weight 3 oz (85g)

 

Principal Display Panel - Carton 3.0 oz
ANALGESIC CREME RUB 
trolamine salicylate 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5857
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5857-561 in 1 CARTON05/10/201408/06/2018
185 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 finalpart34805/10/201408/06/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
 
Major Pharmaceuticals