Hydrocortisone Cream 1%

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrocortisone acetate 1%{relative};  ; Hydrocortisone acetate 1%{relative}

Available from:

Multichem NZ Limited

INN (International Name):

Hydrocortisone acetate 1% w/w

Dosage:

1% w/w

Pharmaceutical form:

Topical cream

Composition:

Active: Hydrocortisone acetate 1%{relative}   Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Citric acid Dimeticone Disodium edetate Glycerol Light liquid paraffin Propylene glycol Purified water Sodium citrate White soft paraffin Active: Hydrocortisone acetate 1%{relative} Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Citric acid Liquid paraffin Purified water Sodium citrate White soft paraffin

Units in package:

Tube, aluminium, 15g laquered tube with polypropylene closure, 15 g

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Crystal Pharma SA

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, 15g laquered tube with polypropylene closure - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, 30g laquered tube with polyproplyene closure - 30 g - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2009-05-18

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Hydrocortisone Cream 1% (Ethics)
Page 1 of 6
1.
PRODUCT NAME
Hydrocortisone Cream 1% (Ethics).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains hydrocortisone acetate 1% w/w.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Topical cream.
Hydrocortisone Cream 1% (Ethics) (as hydrocortisone acetate) is a
smooth, white, viscous
cream.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
For the temporary relief of symptoms associated with acute and chronic
corticosteroid
responsive conditions, including minor skin irritations, itching and
rashes due to eczema,
dermatitis, (such as rashes due to cosmetics and jewellery),
psoriasis, anogenital pruritus, and
sunburn.
4.2
Dose and method of administration
Adults and children 2 years of age and older
Apply to affected area not more than 3 – 4 times daily.
Children under 2 years of age
Do not use, consult a doctor.
Reduce the number of applications as symptoms subside.
Hydrocortisone Cream 1% (Ethics) should not be used under bandages or
dressings except on
medical advice.
4.3
Contraindications
Hypersensitivity to hydrocortisone acetate or to any of the excipients
listed in Section 6.1.
•
Do not use on acne
•
Hypersensitivity to any of the ingredients
•
Do not use in the eye
Like all other topical corticosteroids, Hydrocortisone Cream 1%
(Ethics) is contraindicated in
skin infections and infestations such as chicken pox, herpes and other
viral infections.
NEW ZEALAND DATA SHEET
Hydrocortisone Cream 1% (Ethics)
Page 2 of 6
Hydrocortisone may mask signs of infection. If any infection is
present, an appropriate anti-
infective agent should be used first. Hydrocortisone Cream 1% (Ethics)
may be used to
reduce inflammation but if a favourable response does not occur
promptly then use of the
product should be discontinued until the infection has been adequately
controlled.
If any skin irritation develops discontinue use and treat
appropriately. If extensive areas are
treated, or if occlusive dressings are used, the poss