AVAPTA- hexylresorcinol spray 
Neel Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AVAPTA Toothache Pain Relief

Drug Facts


Active Ingredients

Hexylresorcinol 0.1%

Purpose

Oral Anesthetic

Uses

  • For the temporary relief of pain due to
  • Toothaches
  • Braces
  • Dentures
  • Minor Dental Procedures

Warnings

Allergy alert:

  • Do not use this product if you have a history of allergy to clove or its component, eugenol.
  • Do not swallow

When using this product

  • Do not use more that directed for more than 7 days unless directed by a dentist or doctor
  • This product is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted.

Stop use and ask a doctor if

  • Symptoms do not improve in 7 days
  • Irritation, pain, or redness persists or worsens.
  • Swelling, rash or fever develops.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Shake lightly before use
  • Adults and children 2 years and older, apply to affected area up to 4 times daily or as directed by a dentist or doctor
  • Children under 12 years of age should be supervised when using this product
  • Children under 2, ask a doctor
  • Spray directly, apply with Q-tip or spray on cotton ball or gauze and apply.

Inactive ingredients

Aloe Vera Whole Leaf Extract, Clove Oil, Mentha Arvensis Leaf Extract, Melaleuca Alternifolia (tea tree) Leaf Oil, Morinda Citrifolia Fruit Extract, Purified Wanter, Saline, Titanium Dioxide, Vinegar, Flavor, Xanthan Gum

Questions?

1-859-509-0436

Principal Display Panel

AVAPTA

Toothache Pain Relief

Oral Anesthetic

NDC#76332-004-02

For Pain Associated With

  • Toothaches
  • Braces
  • Dentures
  • Minor Dental Procedures

99.9% ALL NATURAL PLANT BASED INGREDIENTS

  • No Alcohol
  • No Parabens
  • No Benzocaine
  • No Petroleum

Manufactured for

Neel Products LLC

1900 Woodlake Rd

Stamping Ground, KY 40379

info@avapta.com

76332-004

AVAPTA 
hexylresorcinol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76332-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N) HEXYLRESORCINOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CLOVE OIL (UNII: 578389D6D0)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
TEA TREE OIL (UNII: VIF565UC2G)  
NONI FRUIT (UNII: 7829X3G2X5)  
ACETIC ACID (UNII: Q40Q9N063P)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76332-004-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/201210/13/2015
2NDC:76332-004-0289 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/201210/13/2015
3NDC:76332-004-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/201210/13/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/16/201210/13/2015
Labeler - Neel Products LLC (968478102)

Revised: 10/2015
 
Neel Products LLC