Orajel Toothache Rinse BENZYL ALCOHOL ZINC CHLORIDE CHURCH & DWIGHT CO., INC. FDA Approved Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat
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Substance Benzyl Alcohol
Route
TOPICAL
Applications
M022

Drug Facts

Composition & Profile

Active Ingredients
Benzyl Alcohol 0.27% Zinc Chloride 0.15%
Inactive Ingredients
Inactive Ingredients alcohol (4.1% by volume) blue 1 disodium pyrophosphate menthol methyl salicylate poloxamer 338 polysorbate 20 sodium benzoate sodium saccharin sorbitol tetrasodium pyrophosphate water
Strengths
0.27 % 0.15 %
Quantities
2 ml
Treats Conditions
Use For Temporary Relief Of Pain Due To Toothaches Minor Irritation Of The Mouth And Gums Occasional Minor Irritation Pain Sore Mouth And Sore Throat

Identifiers & Packaging

Container Type UNKNOWN
UNII
LKG8494WBH 86Q357L16B
Packaging

#1 ORAL PAIN RELIEVER BRAND FOR TOOTHACHE NON-NUMBING RELIEF! Orajel™ For TOOTHACHE Analgesic & Astringent Rinse Provides All-Over Oral Pain Relief Soothes Irritated Gums Cleans Affected Area Kills Odor-Causing Bacteria Soothing Mint Rinse ORAL PAIN RELIEVER/ ASTRINGENT 16 FL OZ (473.2 mL) DA2011186_OJLBF-43001-02_72013520

Package Descriptions
  • #1 ORAL PAIN RELIEVER BRAND FOR TOOTHACHE NON-NUMBING RELIEF! Orajel™ For TOOTHACHE Analgesic & Astringent Rinse Provides All-Over Oral Pain Relief Soothes Irritated Gums Cleans Affected Area Kills Odor-Causing Bacteria Soothing Mint Rinse ORAL PAIN RELIEVER/ ASTRINGENT 16 FL OZ (473.2 mL) DA2011186_OJLBF-43001-02_72013520

Overview

Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat

Indications & Usage

Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat

Dosage & Administration

Directions • remove imprinted safety seal from bottle cap • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age or over: Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age: Should be supervised in the use of this product Children under 2 years of age: Consult a dentist or healthcare provider Other Information • cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing

Warnings & Precautions
Warnings Do not use this product for more than 7 days unless directed by a dentist or healthcare provider
Purpose

Oral pain reliever Oral astringent

When Using

When using this product • do not swallow • do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and see your physician promptly if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Keep Out of Reach of Children

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Questions

Questions or comments calls us at 800 952 5080 Monday through Friday 9 to 5 ET or visit our website at www orajel com


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