EQUIPTO - BACLOFEN EXTERNAL CREAM COMPOUNDING KIT- baclofen
Alvix Laboratories, LLC
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.
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Equipto-Baclofen External Cream Compounding Kit
For Pharmacy Prescription Compounding Only / Rx Only
For Topical Use Only
DESCRIPTION
Baclofen 2% External Cream Base
FOR PRESCRIPTION COMPOUNDING ONLY / Rx Only
Each Equipto - Baclofen External Cream Compounding Kit provides 2.04 grams of Baclofen powder for incorporation into 100 grams of a Base. The resulting mixture is intended for topical use.
CAS Number 1134-47-0
β-(4-chlorophenyl)-γ-aminobutyric acid (β-(4-chlorophenyl)-GABA)
WARNINGS
Pictogram
Signal word: Danger
Hazard Statement(s)
H301 Toxic if swallowed.
H315 Causes skin irritation.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335 May cause respiratory irritation.
H360 May damage fertility or the unborn child.
Precautionary statement(s)
P201 Obtain special instructions before use.
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P280 Wear protective gloves.
P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/
physician.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
KTI COMPONENTS
Kit Components: 1 color coded black bottle of 2.04g Baclofen, 1 bottle of 100g Base, 1 stirring rod, and 1 empty white mixing jar.
| SIZE | 120 grams |
| NDC # | 15455-0701-2 |
| Baclofen | 2.04 grams |
| Base | 100 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 - Baclofen External Cream Compounding Kit to cure, treat, or mitigate disease.
Equipto - Baclofen 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 - Baclofen External Cream Compounding Kit at room temperature between 15 - 30 degrees C (59 - 86 degrees F). Protect from light.
For external use only.
| EQUIPTO - BACLOFEN EXTERNAL CREAM COMPOUNDING KIT
baclofen kit |
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| Labeler - Alvix Laboratories, LLC (962445925) |