OILATUM LIQUID

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

MINERAL OIL LIGHT

제공처:

GLAXOSMITHKLINE INC

ATC 코드:

D02AC

INN (국제 이름):

SOFT PARAFFIN AND FAT PRODUCTS

복용량:

63.4%

약제 형태:

LIQUID

구성:

MINERAL OIL LIGHT 63.4%

관리 경로:

TOPICAL

패키지 단위:

250ML

처방전 유형:

OTC

치료 영역:

BASIC OINTMENTS AND PROTECTANTS

제품 요약:

Active ingredient group (AIG) number: 0126693003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-02-28

제품 특성 요약

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PRESCRIBING INFORMATION
OILATUM
®
Light Liquid Paraffin (LLP), 63.40% w/w
DERMATOLOGICAL SHOWER AND BATH OIL
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Revision:
May 7, 2013
Submission Control No: 161615
_©_
_ 2013 GlaxoSmithKline Inc. All Rights Reserved_
®
_ OILATUM is under license by GlaxoSmithKline Inc. _
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OILATUM
®
Light Liquid Paraffin (LLP), 63.40% w/w
THERAPEUTIC CLASSIFICATION
Dermatologicals, other emollients and protectives
INDICATIONS AND CLINICAL USE
OILATUM
®
(Light Liquid Paraffin (LLP), 63.40% w/w) relieves dry, itchy,
sensitive skin,
softens and hydrates the skin and helps protect against further
drying.
CONTRAINDICATIONS
No contraindications identified.
WARNINGS AND PRECAUTIONS
OILATUM
®
should be used with caution in patients with a known sensitivity to
LLP or to
any of the excipients in the preparation.
OILATUM
®
is for
external use only. Patients should be advised to avoid contact with
the
eyes. If contact occurs, rinse with water. If skin irritation occurs,
patients should
discontinue use. Patients should be advised to consult a healthcare
practitioner of
symptoms worsen or last for more than 7 days.
SEXUAL FUNCTION/REPRODUCTION
There are no data on the use of cutaneous LLP on human fertility.
SPECIAL POPULATIONS
PREGNANT WOMEN: No effects during pregnancy are anticipated, since
systemic
exposure to LLP is expected to be low
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NURSING WOMEN: It is not known if LLP is excreted in human milk. Risk
to the infant is
likely to be low since systemic exposure is low.
Patients should be advised to ensure that any residual product is
fully washed off the
breast prior to breast-feeding.
ADVERSE REACTIONS
Adverse drug reactions (ADRs) are listed below by MedDRA system organ
class and by
frequency. Frequen