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Which Dimethicone is OTC skin protector
Is dimethicone 5cst at %1-2 an OTC Skin protectant active ingredient?
If not then which dimethicone is?
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12 Replies
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In Europe, dimethicone is not an active ingredient but an excipient.
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@Pharma how about us?
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the cfr does not specify from what I can tell
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=347&showFR=1 -
I don’t recall, but when we needed to know we accessed an old patent. *Scar Products” I ‘believe” it was the 200 cst or higher.
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@EVchem @Microformulation thanks
In this list Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil is a skin protectant. Is it really that effective at such small quantity?
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@Abdullah - I suspect the colloidal oatmeal makes no difference
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@Perry thanks
So why would they list it as skin protectant in such small quantity?
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@Abdullah - It’s likely that someone, somewhere had a study that demonstrated an effect in combination with mineral oil. But I would say that is probably just an anomaly and it probably doesn’t have a real impact. Just my opinion though.
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@Perry thanks.
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From OTC Skin Protectant Monograph (https://www.govinfo.gov/content/pkg/FR-2003-06-04/pdf/03-13751.pdf)
(f) Colloidal oatmeal, 0.007 percent
minimum; 0.003 percent minimum in
combination with mineral oil in
accordance with § 347.20(a)(4).(g) Dimethicone, 1 to 30 percent
(l) Mineral oil, 50 to 100 percent; 30
to 35 percent in combination with
colloidal oatmeal in accordance with
§ 347.20(a)(4). -
@PhilGeis - I saw that. I just am skeptical that even though there was enough evidence to convince regulators to include colloidal oatmeal at those low levels in the monograph, I doubt it provides any noticeable benefit over just using mineral oil alone. I’m sure they have a study that demonstrates an effect. I just remain skeptical and without replication see it as a statistical anomaly.
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Me too Perry. Here’s what they say about % -
The agency has reviewed the
recommended concentrations of
colloidal oatmeal reported in the
literature and reference texts (Refs. 4, 29
through 32, 34 through 45, 47, 48, and
49) and has considered the range ofoncentrations for colloidal oatmeal
used in bath additive products and in
other dosage forms. Products containing
colloidal oatmeal have been formulated
in the following dosage forms: Lotion (1
and 10 percent colloidal oatmeal),
cleansing cream (8 percent colloidal
oatmeal), shampoo (5 percent colloidal
oatmeal), and cleansing bars (30, 50, and
51 percent colloidal oatmeal) (Refs. 4,
46, and 47). The agency has calculated
the approximate minimum and
maximum concentrations of colloidal
oatmeal that have been used as follows:
For regular colloidal oatmeal, a range of
0.023 to 0.625 percent when used as a
tub bath soak (Refs. 29, 34 through 38,
and 44), a range of 0.24 to 1.2 percent
when used as a foot bath soak (Refs. 30,
31, and 34), a range of 0.24 to 15 percent
in aqueous solution when used in a wet
pack (Refs. 30, 31, 32, 34, and 45), and
a range of 3.75 to 15 percent in aqueous
solution when used as a topical lotion
(Refs. 30, 32, and 34); for oilated
colloidal oatmeal, a range of 0.003 to
0.03 percent when used as a tub bath
soak (Refs. 35 and 39 through 43).
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