Analgesic Creme Rub by Major Pharmaceuticals / Faria LLC Dba Sheffield Pharmaceuticals

Analgesic Creme Rub by

Drug Labeling and Warnings

Analgesic Creme Rub by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Faria LLC Dba Sheffield Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - Carton 3.0 oz

Major                                                              NDC: 0904-5857-56

Trolamine Salicylate 10%

Analgesic Creme Rub with aloe

                                                                      Net Weight 3 oz (85g)

 

ANALGESIC CREME RUB 
trolamine salicylate 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5857
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	100 mg  in 1 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)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5857-56	1 in 1 CARTON	05/10/2014	08/06/2018
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	05/10/2014	08/06/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: 689f2491-3afe-40ad-bca7-4c3053ff8c5c

34390-5

Set id: 3bf5a35f-cade-4594-8ae4-75ebca0c2146

Version: 2

Effective Time: 20200103