Label: MY FAIR BABY ORAL GEL INSTANT PAIN RELIEF- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 47046-180-01, 47046-180-02 - Packager: Anicare Pharmaceuticals Pvt. Ltd.
- 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 December 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a physician if
- Keep out of reach of children
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Directions
■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider
- Other information
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
MY FAIR BABY ORAL GEL INSTANT PAIN RELIEF
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47046-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GELATIN (UNII: 2G86QN327L) MINERAL OIL (UNII: T5L8T28FGP) PECTIN (UNII: 89NA02M4RX) PETROLATUM (UNII: 4T6H12BN9U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47046-180-02 1 in 1 BOX 12/01/2020 1 NDC:47046-180-01 14 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 06/15/2014 Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)