Doxepin Hydrochloride Cream

Mylan Inc

Revision date : 2025-09-22

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GHS07 GHS09
Health risk rating 4
Safety risk rating 1
Environmental risk rating 4

Note: Ingredients listed on restricted chemical lists

General Information

Version

2.5

Revision date

2025-09-22

Product name

Doxepin Hydrochloride Cream

Product Synonyms

Doxepin HCl Cream; PRUDOXIN (Doxepin HCl 5%) Cream; ZONALON® (doxepin hydrochloride) Cream 5%

1.2.1 Relevant identified uses

Pharmaceutical. Use only as directed. For external use only The intent of this safety data sheet (SDS) is to provide safety information for occupational handling of this product. This information may not be relevant for medical use of this product. Pati...

Emergency telephone

+1-813-248-0585, 1-800-255-39...

Icons in SDS

GHS07 GHS09 M004 M009 M010 M011 M017

Company Information

company name

Mylan Inc

e-mail address of the competent person responsible for the Safety Data Sheet

SDScontact@viatris.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H336, H362, H411

Hazard statements

Code

Statements

H336

May cause drowsiness or dizziness

Section 2

SECTION 2: Hazards identification

Pharmaceutical Agent – Handling of this product in its final form presents minimal occupational exposure risk Patients/Consumers: Please refer to the product information insert or product label for appropriate consumer-specific information about this product when used according to the physician’s directions

2.1 Classification of the substance or mixture

Effects on or via lactation, Yes Specific target organ toxicity (single exposure), Category 3 [ Narcotic effects ] Chronic aquatic toxicity, Category 2

Signal word

Warning

Hazard statements

H362 - May cause harm to breast-fed children H336 - May cause drowsiness or dizziness H411 - Toxic to aquatic life with long lasting effects

Prevention

Obtain special instructions before use Do not breathe dust/fume/gas/mist/vapors/spray Avoid contact during pregnancy/while nursing Wash face, hands and any exposed skin thoroughly after handling Do not eat, drink or smoke when using this product Use only outdoors or in a well-ventilated area Avoid release to the environment

Response

Inhalation Spill IF exposed or concerned: Get medical advice/attention IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing Collect spillage

Storage

Store in a well-ventilated place. Keep container tightly closed Store locked up

Precautionary statements

Disposal Dispose of contents/container to an approved waste disposal plant

Other hazards

No information available Unknown acute toxicity No information available

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