ULCEREASE- phenol 0.6% anesthetic oral rinse rinse

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)

Disponible depuis:

Crown Laboratories

Mode d'administration:

ORAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

Anesthetic/Analgesic Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.

Statut de autorisation:

OTC monograph not final

Résumé des caractéristiques du produit

ULCEREASE- PHENOL 0.6% ANESTHETIC ORAL RINSE RINSE
CROWN LABORATORIES
----------
ULCEREASE ANESTHETIC MOUTH RINSE
0.6 % Phenol
Anesthetic/Analgesic
Temporary relief of occasional minor irritation, pain, sore mouth,
sore throat, canker
sores and teething.
• Keep out of reach of children. • Not for ingestion.
• If sore throat is severe, persists for more than 2 days, is
accompanied or followed by
fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
If sore mouth
symptoms do not improve in 7 days, see your dentist or doctor
promptly.
• Keep out of reach of children.
• Shake well prior to use.
• Use full strength as a mouth rinse, rinsing affected area for 15
seconds and spitting
out the remainder of the product.
• For upper throat, gargle for 15 seconds and spit out.
• For adults and children over 12 years of age use every 2 hours or
as needed; do not
use more than 12 times per day.
• Children ages 4 months to under 12 years of age, apply to affected
area with clean
swab. Use up to 6 times daily or as directed by physician or dentist.
• For teething and hard to reach areas, apply directly to area with
tip of clean swab,
repeat up to 6 times daily.
Store at room temperature 20°–25°C (68°–77°F) [See USP
Controlled Room
Temperature].
Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.
TAMPER RESISTANT SEAL–IF SEAL IS BROKEN DO NOT USE.
NDC 0316-0100-06
ULCEREASE
Anesthetic Mouth Rinse
Quick pain relief for mouth and upper throat irritations
CONTAINS: NO SUGAR, NO ALCOHOL, NO ARTIFICIAL DYES OR COLORINGS.
PLEASANT TO USE.
Manufactured and Distributed by: Crown Laboratories Inc.,
Johnson City, TN 37604
800.334.4286
www.crownlaboratories.com
P6028.03
®
ULCEREASE
phenol 0.6% anesthetic oral rinse rinse
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0316-0100
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)
PHENOL
6 mg in 1 mL
INACTIV