Monograph: Medicated Skin Care Products

Date: 2018-12-07

NHPID name

• Kaolin ( O'Neil et al. 2012 )
• Starch - Maize ( Germplasm Resources Information Network Taxonomy )
• Theobroma Oil ( Germplasm Resources Information Network Taxonomy )
• Lanolin ( USP 2008a )
• Sodium bicarbonate ( British Pharmacopoeia Online )
• Adeps solidus ( ChemIDplus Advanced )
• Zinc acetate ( USP 2008a )
• Zinc oxide ( The Merck Index Online )
• Olive Oil ( Germplasm Resources Information Network Taxonomy )
• DL-Lactic acid ( O'Neil et al. 2012 )
• Allantoin ( O'Neil et al. 2012 )
• Mineral oil ( USP 2008 )
• Almond Oil ( Germplasm Resources Information Network Taxonomy )
• Calamine ( British Pharmacopoeia Online )
• Glycerol ( British Pharmacopoeia Online )
• Colloidal oatmeal ( Germplasm Resources Information Network Taxonomy )
• Aluminum hydroxide ( USP 2008a )
• Zinc carbonate ( USAN Council 1998 )
• Cod Liver Oil
• Petrolatum ( O'Neil et al. 2012 )
• Dimethicone ( O'Neil et al. 2012 )
• White petrolatum ( USP 2008a )
• Urea ( British Pharmacopoeia Online )

Proper name(s)

Common name(s)

Medicated Skin Care Products

Source material

Route Of administration

Topical

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

• Temporarily protects and helps relieve minor skin irritation and itching.  (Bingham and Cummings 1983)
• Temporarily dries the oozing and weeping and helps relieve minor skin irritation and itching due to poison ivy/oak/sumac.  (Naguib 2000)
• Temporarily protects and helps relieve minor skin irritation and itching due to minor cuts, scrapes and burns.  (Bingham and Cummings 1983)
• Temporarily protects and helps relieve minor skin irritation and itching due to poison ivy/oak/sumac, and insect bites.  (Bingham and Cummings 1983)
• Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy/oak/sumac, and insect bites.  (Rosenthal et al. 2006)
• Temporarily protects and helps relieve minor skin irritation and itching due to (rashes)(and/ or)(eczema).  (Stene and Joner 2003)

Dose(s)

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s):

• For external use only.
• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
• Stop use and ask/consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if symptoms worsen or last for more than 7 days.
• This product contains lactic acid [an alpha-hydroxy acid (AHA)] which may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Limit sun exposure and apply a sunburn protectant while using this product and for a week afterwards.
• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• When using this product in some skin conditions, soaking too long may over-dry the skin.
• When using this product keep powder away from face to avoid inhalation, which can cause breathing problems.

Contraindication(s):

• Do not use on broken skin.
• Do not use on children less than 2 years of age, unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional.
• Not intended for use on deep or puncture wounds, animal bites or serious burns.

Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of natural health products guide.
• The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).