Label: ORAJEL INSTANT PAIN RELIEF SEVERE- benzocaine 20%, menthol, benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10237-752-25 - Packager: Church Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 4, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- DO NOT USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions - cut open tip of tube on score mark
- Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
- Children under 12 years of age - Should be supervised in the use of this product
- Children under 2 years of age - Ask a physicaian or healthcare provider
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Other information
- do not use if tube tip is cut prior to opening
- this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
- do not use continuously
- Orajel Severe Pain 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
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
#1
ORAL PAIN
Reliever for Toothache
Now with 3X More
Active Ingredients vs. Store Brand
Orajel™
Instant Pain Relief
SEVERE
Toothache & Gum Relief Plus
TRIPLE MEDICATED
20% Benzocaine to Relieve Oral Pain
Antiseptic to Help Prevent Infection
Menthol to Soothe
FAST-ACTING
GEL
Oral Pain Reliever/Antiseptic NET WT. 0.25 OZ (7.0g)
OJFC-32503-06
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INGREDIENTS AND APPEARANCE
ORAJEL INSTANT PAIN RELIEF SEVERE
benzocaine 20%, menthol, benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-752 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYL SALICYLATE (UNII: LAV5U5022Y) MINERAL OIL (UNII: T5L8T28FGP) PECTIN (UNII: 89NA02M4RX) PETROLATUM (UNII: 4T6H12BN9U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-752-25 1 in 1 CARTON 12/26/2016 02/27/2017 1 7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/15/2013 Labeler - Church Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church Dwight Co., Inc. 043690812 manufacture(10237-752)