Pramoxine hydrochloride

329.86

329.175781

211-293-1

88AYB867L5

757847|25573

DTXSID2047777

C47682

Crystals

2934999090

30.93000

3.70650

White or off white crystalline powder

181-183 °C

427ºC at 760 mmHg

123.5ºC

>49.5 [ug/mL]

Preparations containing pramoxine hydrochloride cream or ointment should be stored in tight containers at at temperatures of 15-30 deg C. Pramoxine hydrochloride aerosol preparations should be stored at room temperature. Because the contents are under pressure, the aerosol container should not be punctured, used or stored near hear or an open flame, exposed to temperatures greater than 49 deg C, ... .

LD50 i.v. in mice: 79.5 ±2.7 mg/kg (Schmidt); LD50 in mice (mg/kg): 300 i.p., 750 s.c. (Monash, Gibbs)

178.8 Ų [M+H]+ [CCS Type: TW, Method: calibrated with polyalanine and drug standards]

NONH for all modes of transport

3

22-36/37/38

26-36

QD8750000

Xi,Xn

P261-P305 + P351 + P338

H302-H315-H319-H335

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal, aquatic, and plant life; and conformance with environmental and public health regulations.|Because the contents are under pressure, the aerosol container should not be ... placed into a fire or /SRP: pathological/ incinerator for disposal.

Anorectal drug products for over-the-counter human use. Local anesthetic active ingredients. The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient: pramoxine hydrochloride 1 percent.|Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: pramoxine hydrochloride is included in anorectal drug products.

|Warning|H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]|P261, P264, P270, P271, P280, P301+P312, P302+P352, P304+P340, P305+P351+P338, P312, P321, P330, P332+P313, P337+P313, P362, P403+P233, P405, and P501|Aggregated GHS information provided by 82 companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

LD50 Mouse ip 300 mg/kg|LD50 Mouse sc 750 mg/kg

NIOSH (NOES Survey 1981-1983) has statistically estimated that 16,892 workers (15,582 of these are female) are potentially exposed to pramoxine hydrochloride in the US(1).

Anesthetic (local)|Indicated for the symptomatic relief of: hemorrhoids, anorectal inflammation and anorectal pain. (these medications /including pramoxine/ are effective when applied to the anal, periana, or anorectal areas. However, they are not likely to relieve symptoms associated with conditions confined to the rectum, which lacks sensory nerve fibers.) /Included in US product labeling/|Pramoxine preparations are used topically for the temporary relief of pain and itching associated with dermatoses; rashes due to poison ivy, poison oak, poison sumac, insect bites; minor burns; anogenital pruritus or irritation; and fissures; or hemorrhoids. The drug should not be used for bronchoscopy or gastroscopy since it is not sufficiently potent to abolish the gag reflex.

Local effects, such as burning or stinging, may occur following topical application of pramoxine. The drug has a low index of sensitization, and cross-sensitization with other local anesthetics is unlikely.|Topical pramoxine preparations should not be used in or near the eyes or nose.|The preparations should not be applied to extensive areas of skin and are not for prolonged use. The aerosol foam for rectal administration should not be used longer than 4 consecutive weeks.|If pramoxine preparations are used for self-medication and the condition worsens or symptoms persist for prolonged periods (e.g., for more than 7 days) or clear and occur again within a few days, the drug should be discontinued and a physician consulted.|If rectal bleeding occurs during use of pramoxine for pain and itching of hemorrhoids or if erythema, irritation, swelling, or pain occurs during use of pramoxine preparations, the drug should be discontinued and a physician consulted.

Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

These agents are readily absorbed through mucous membranes into the systemic circulation. The rate of absorption is influenced by the vascularity or rate of blood flow at the site of application, the total dosage (concentration and volume) administered, and the duration of exposure. ... /Local anesthetics/

Local anesthetics block both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade. /Local anesthetics/

4-(3-(4-butoxyphenoxy)propyl)morpholine

Rectal or Topical: Aerosol, foam suspension: 1% proctoFoam/non-steroid (with parabens), (Schwarz); Cream: 1% Tronolane (with parabens), (Ross). Topical: 1% Hemorrhoidal Anesthetic Cream, (Clay-Park), Tronothane Hydrochloride (with parabens), (Ross); Gell: 1% Itch-X (with SD alcohol 40, benzyl alcohol 10%, parabens, and propylene glycol), (Ascher), PrameGel (with benzyl alcohol and menthol), (GenDerm); Lotion: 1% Prax Lotion, (Ferndale); Pledgets (saturated with solution): 1% Fleet Pain-Relief Pads (with glycerin 12.5%), (Fleet); Solution: 1% Itch-X Spray (with benzyl alcohol 10%), (Ascher).

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients