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Equipto-Amitriptyline Cream

Pronunciation

Dosage Form: compounding kit

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Equipto-Amitriptyline Cream Description

Amitriptyline 2% External Cream Base
FOR PHARMACY PRESCRIPTION COMPOUNDING ONLY / Rx ONLY

Each Equipto - Amitriptyline External Cream Compounding Kit provides 2.4 grams of Amitriptyline powder for incorporation into 117.6 grams of a Base. The resulting mixture is intended for topical use.

CAS-No. : 549-18-8

10,11-Dihydro-N,N-dimethyl-5 H-dibenzo[a,d] cycloheptene-Δ 5, γ-propylamine hydrochloride

Warnings

Pictogram

Signal word Danger Hazard statement(s)

H301 Toxic if swallowed. H361 Suspected of damaging fertility or the unborn child. Precautionary statement(s)

P201 Obtain special instructions before use.

P202 Do not handle until all safety precautions have been read and understood. P264 Wash skin thoroughly after handling.

P270 Do not eat, drink or smoke when using this product.

P281 Use personal protective equipment as required.

P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician.

P308 + P313 IF exposed or concerned: Get medical advice/ attention.

P321 Specific treatment (see supplemental first aid instructions on this label).

P330 Rinse mouth. P405 Store locked up.

P501 Dispose of contents/ container to an approved waste disposal plant.

KIT COMPONENTS

Kit Components: 1 color coded teal bottle of 2.4g Amitriptyline, 1 bottle of 117.6g Base, 1 stirring rod, and 1 empty white mixing jar.

SIZE 120 grams
NDC # 15455-0112-2
Amatriptyline 2.4 grams
Base 117.6 grams

Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of the product after 30 days of being compounded.

* Certificate of analysis on file.

The FDA has not approved Equipto - Amitriptyline External Cream Compounding Kit to cure, treat, or mitigate disease.

Equipto - Amitriptyline External Cream Compounding Kit is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only.

Rx ONLY

STORAGE AND HANDLING

Prior to compounding, store Equipto - Amitriptyline External Cream Compounding Kit at room temperature between 15 - 30 degrees C (59 - 86 degrees F). Protect from light. For external use only.

PRINCIPAL DISPLAY PANEL

NDC 15455-0112-2

Equipto - Amitriptyline External Cream Compounding Kit

Amitriptyline 2% External Cream in Base

FOR PRESCRIPTION COMPOUNDING ONLY

RX ONLY

TDC MAX Cream - Base 117.6 g

NDC# 15455-0999-2

FOR PRESCRIPTION COMPOUNDING ONLY

Rx ONLY

Amatriptyline USP Powder 2.4 g

NDC# 15455-9507-7

FOR PRECSRIPTION COMPOUNDING ONLY

Rx ONLY

INSTRUCTIONS FOR USE

EQUIPTO - AMITRIPTYLINE EXTERNAL CREAM COMPOUNDING KIT 
amitriptyline kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15455-0112
Packaging
# Item Code Package Description
1 NDC:15455-0112-2 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS 2.4 g
Part 2 1 BOTTLE, PLASTIC 117.6 g
Part 1 of 2
AMITRIPTYLINE 
amitriptyline powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 1 g  in 2.4 g
Packaging
# Item Code Package Description
1 2.4 g in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 2 of 2
TDC MAX CREAM 
cream base suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 60  
PEG-150 STEARATE  
STEARETH-20  
WATER  
CETOSTEARYL ALCOHOL  
CYCLOMETHICONE 5  
METHYLISOTHIAZOLINONE  
SORBITOL  
ALOE VERA LEAF  
ALPHA-TOCOPHEROL ACETATE  
EDETATE DISODIUM  
METHYLCHLOROISOTHIAZOLINONE  
ETHYLHEXYL STEARATE  
Packaging
# Item Code Package Description
1 117.6 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/22/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/20/2015
Labeler - Alvix Laboratories, LLC (962445925)
Revised: 11/2015
 
Alvix Laboratories, LLC



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