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Cocoa butter

Generic Name
Cocoa butter
Brand Names
Calmol, Preparation H Reformulated Jun 2013
Drug Type
Biotech
CAS Number
8002-31-1
Unique Ingredient Identifier
512OYT1CRR

Overview

Cocoa butter is an edible natural fat obtained from the Theobroma cocoa seeds that is predominantly found in dark chocolate . It is a rich source of monounsaturated and saturated fatty acids that mainly contains approximately 33% Oleic Acid, 25% Palmitic Acid, and 33% Stearic acid but does not contain caffeine or theobromine. Fat cocoa solids, including cocoa butter, have lower phenolic content than non-fat cocoa solids but may contain some polyphenols of different structures of flavonoids with antioxidant properties . Cocoa butter is included in chocolate and other food products, and can also be found in over-the-counter skin products such as lotions, creams, and bars intended to maintain skin softness. While cocoa butter has skin moisturizing properties, it was not shown to reduce the likelihood of developing of striae gravidarum, or stretch marks, in a double-blind, randomized clinical trial of women in the first trimester . Still, it is a common active ingredient for prevention of skin dryness in cosmetic and skincare products. Oftentimes cocoa butter is used in over-the-counter pharmaceutical products and suppositories. The lipid-lowering effects of cocoa butter have been studied and investigated, as fatty acid constituents of cocoa butter are known to exhibit lipid-lowering properties. Dyslipidemia is characterized by elevated levels of plasma triglyceride and very-low-density lipoprotein (VLDL) cholesterol due to overproduction of large triglyceride-enriched VLDL cholesterol particles . Cocoa butter has shown to reduce VLDL cholesterol levels in animal studies, suggesting its potential use in lipid disorders.

Indication

Indicated for topical use in over-the-counter skin products for the treatment of skin dryness and reduction of striae gravidarum (stretch marks).

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Walgreens
0363-0476
RECTAL
2211 mg in 1 1
7/13/2025
Walgreens
0363-0476
RECTAL
2211 mg in 1 1
7/13/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HEMORRHOIDAL SUPPOSITORIES
h.j. sutton industries ltd.
02446855
Suppository - Rectal
88.44 %
5/20/2016
HEMORRHOIDAL SUPPOSITORIES
triad pharmaceuticals
02290065
Suppository - Rectal
85.5 %
2/1/2007
HEMORRHOIDAL SUPPOSITORIES
pharma pac llc
02382156
Suppository - Rectal
85.5 % / W/W
9/7/2012
SUPPO-H 1000MG/SUP
santrel international inc.
02004720
Suppository - Rectal
1 G / SUP
12/31/1992
SUPPO H SUP 1000MG
produits aloex ltee
02006324
Suppository - Rectal
1 G / SUP
6/27/1996
XYRALID HEMORRHOIDAL SUPPOSITORIES
innovus pharmaceuticals inc
02484021
Suppository - Rectal
88.44 % / W/W
N/A
APZ HEMORRHOIDAL SUPPOSITORIES
apz pharmaceutical corporation
02396173
Suppository - Rectal
85.5 % / W/W
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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License Number
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Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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