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NDC 49035-0361-19 equate Severe Toothache and Gum Relief .1; 20; .5 g/100g; g/100g; g/100g Details
equate Severe Toothache and Gum Relief .1; 20; .5 g/100g; g/100g; g/100g
equate Severe Toothache and Gum Relief is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL.
Product Information
NDC | 49035-0361 |
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Product ID | 49035-361_c73ef91b-f5ee-4ba6-e053-2a95a90ade94 |
Associated GPIs | 43994003270320 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | equate Severe Toothache and Gum Relief |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzocaine, menthol, benzalkonium chloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | DENTAL |
Active Ingredient Strength | .1; 20; .5 |
Active Ingredient Units | g/100g; g/100g; g/100g |
Substance Name | BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL |
Labeler Name | Wal-Mart Stores Inc |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | n/a |
Package
Package Images

NDC 49035-0361-19 (49035036119)
NDC Package Code | 49035-361-19 |
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Billing NDC | 49035036119 |
Package | 1 TUBE in 1 BOX (49035-361-19) / 7 g in 1 TUBE |
Marketing Start Date | 2018-11-02 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 799d957b-4510-5507-e053-2991aa0ad60d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must
be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have
used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
• pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or
lightheadedness • fatigue or lack of energy
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions • cut open tip of tube on score mark • adults and children 2 years of age and older: apply a small
amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by
a dentist or doctor • children between 2 and 12 years of age should be supervised in the use of this product
• children under 2 years of age: do not use
SPL UNCLASSIFIED SECTION
Other information • do not use if tip is cut prior to opening • this preparation is intended for use in cases of
toothache, only as a temporary expedient until a dentist can be consulted • do not use continuously • this formula
will stay in place for extended duration of relief • avoid using toothpaste or drinking soft drinks or fruit juices for at
least one hour after applying
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
equate
Triple Medicated
Severe Toothache
& Gum Relief
Oral Pain Reliever / Antiseptic
Immediate Relief of Intense Pain
- Maximum strength BENZOCAINE for toothache pain relief
- Antiseptic to help prevent infection
- Soothing menthol for gums
Fast Acting Gel
Compare to Orajel™ Severe Triple Medicated Gel Active Ingredients*
Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
DISTRIBUTED BY: Wal-Mart Stores, Inc. Bentonville, AR 72716
*This product is not manufactured or distributed by Church & Dwight Co. Inc., makers of Orajel™.
TAMPER-EVIDENT:
Do not use if tube tip is cut prior to use
INGREDIENTS AND APPEARANCE
EQUATE SEVERE TOOTHACHE AND GUM RELIEF
benzocaine, menthol, benzalkonium chloride gel |
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Labeler - Wal-Mart Stores Inc (051957769) |
Registrant - Lornamead (080046418) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Lornamead | 080046418 | manufacture(49035-361) |