INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CALADRYL LOTION
CALADRYL CREAM
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CALADRYL LOTION
CALADRYL CREAM

COMPOSITION:
(1) Caladryl Lotion contains per 1 mL: 
  Diphenhydramine hydrochloride         10,0 mg
  Calamine         81,709 mg
  Alcohol         2,2% v/v
(2) Caladryl Cream contains per 1 g: 
  Diphenhydramine hydrochloride         10,0 mg
  Calamine         84,11 mg
  Preservative: Propylparaben         0,17% m/v

PHARMACOLOGICAL CLASSIFICATION:
A: 13.4 Antipruritics

PHARMACOLOGICAL ACTION:
Diphenhydramine hydrochloride provides local antihistaminic action while calamine has a soothing effect on irritated skin.

INDICATIONS:
Caladryl Lotion and Caladryl Cream are indicated for the relief of irritations due to insect bites and stings, sunburn and skin rashes.

CONTRA-INDICATIONS:
Known sensitivity to the ingredients.

WARNING:
Contains CAMPHOR which may be harmful if swallowed. For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Caladryl Lotion and/or Cream should be applied two or three times daily to the affected areas.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Should not be used in or near the eyes. Should not be applied to raw or oozing areas of the skin. Discontinue use if burning sensation or rash develops or condition persists. Remove by washing with soap and water.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The toxicity of calamine is not known, but the estimated lethal dose is thought to be 5 to 15g/kg. The toxicity of diphenhydramine hydrochloride is relatively greater - 5 to 50 mg/kg (probably closer to the higher value).
Although no cases of Caladryl poisoning are on record, the symptoms are most likely to be those of diphenhydramine hydrochloride overdosage.
Diphenhydramine hydrochloride poisoning often resembles atropine poisoning, particularly in children who appear to be more susceptible to the stimulating effect of the drug than adults. Tinnitus, visual and olfactory hallucinations, nervousness, excitement and ataxia may occur. Dry mouth, constipation, urinary retention, fixed and dilated pupils, flushed face, and hyperthermia (especially in children) are common.
Treatment
Gastric lavage should be done, especially if the patient is seen within four hours of the time the drug was ingested. Symptomatic and supportive therapy should be given as needed. Stimulants should not be used.

IDENTIFICATION:
Caladryl Lotion:        Red-pink, opaque liquid with a camphor odour.
Caladryl Cream        Red-pink, opaque cream with a camphor odour.

PRESENTATION:
Caladryl Lotion:        Bottles of 100 mL
Caladryl Cream:        Tubes of 42g

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). KEEP OUT OF THE REACH OF CHILDREN.

REFERENCE NUMBERS:
Caladryl Lotion:         G2082 (Act 101/1965)
Caladryl Cream:         G2081 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14 November 1974.

Updated on this site: May 2003
Source: Pharmaceutical Industry

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