Label: FORMULA 2 SKIN CARE- lidocaine 5% cream
- NDC Code(s): 72839-265-00
- Packager: Derma Care Research Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated March 9, 2020
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- ACTIVE INGREDIENT
For external use only.
When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
- Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
- Children under 12 years of age: consult a doctor.
- To use finger cots: roll one finger cot over a finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
FORMULA 2 SKIN CARE
lidocaine 5% cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CHOLESTEROL (UNII: 97C5T2UQ7J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-265-00 28 g in 1 TUBE; Type 0: Not a Combination Product 03/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/09/2020 Labeler - Derma Care Research Labs (116817470) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derrma Care Research Labs 116817470 manufacture(72839-265)