Hydro Ear Drops

Each 1 mL for otic administration contains:

Hydrocortisone 10 mg

Pramoxine Hydrochloride 10 mg

Chloroxylenol 1 mg

Benzalkonium Chloride 0.10 mg

In a non-aqueous propylene glycol vehicle with 3% propylene glycol diacetate.

Chloroxylenol:

4-chloro-3.5 dimethylphenol is a broad spectrum bactericidal agent which occurs as white crystals with a phenolic odor. It is soluble in alcohol, ether, and alkali hydroxides.

Hydrocortisone:

11, 17, 21, trihydroxy, (11 b)-Pregn-4-ene-3,20-dione, is an anti-inflammatory and antipruritic agent. It occurs as a white to practically white, odorless, crystalline powder which melts at about 215 °C with decomposition. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

Pramoxine hydrochloride:

4[3-(4-butoxyphenoxy) propyl] - Morpholine hydrochloride is a topical anesthetic proven to be safe and effective in hospital tests. It occurs as a white to practically white, crystalline powder, having a numbing taste and it may have a slight aromatic odor. The pH of a solution (1 in 100) is about 4.5, it is freely soluble in water and in alcohol; soluble in chloroform; and very slightly soluble in ether.

Benzalkonium chloride:

Action lowers surface tension permitting greater penetration to meatal skin. It also is a cationic germicide of high bactericidal and bacteriostatic potency.

For the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms and susceptible to the action of the antimicrobial. May also be used to control itching in the auditory canal.

This preparation is not intended for ophthalmic or oral use. If accidental ingestion occurs, seek professional help. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

The following adverse reactions with topical corticosteroids have been observed: itching, burning, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects.