Label: TATOO CARE- lidocaine cream
- NDC Code(s): 83527-1001-1
- Packager: INDUSTRIAS QUIMICAS INDEPENDENCIA SA
- 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.
Drug Label Information
Updated June 16, 2023
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Package label
Ask your doctor
If any side effect is observed, discontinue use and consult your healthcare practicioner
Directions
Wash the specific area with soap and warm water to open pores and dry. Apply a thick and even layer of the product
Warnings
For external use only.
- Before using this product perform an allergy test by applying a small amount of product on the forearm. If no side effect appear after 30 minutes, such asredness, irritation or itching, you can start applying it.
- Keep out of the reaching of children
- The use of this product has not been tested in areas such as eyes contours and mucus membranes.
- Do not use if allergic to lidocaine or other local anesthetics
- For all kind of skin
- If any side effect is observed, discontinue use and consult your healthcare practicioner
Inactive ingredients
WATER, CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE, GLYCERIN, C13-14 ISOPARAFFIN/LAURETH-7/POLYACRYLAMIDE, CYCLOMETHICONE, JOJOBA OIL, GLYCERYL STEARATE /PEG-100 STEARATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, PHENOXYETHANOL & ETHYLHEXYLGLYCERIN, ALPHA TOCOPHEROL ACETATE, DL ALOE VERA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, DIMETHICONE 350, EDETATE DISODIUM, SODIUM HYDROXIDE
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INGREDIENTS AND APPEARANCE
TATOO CARE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83527-1001 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 WATER (UNII: 059QF0KO0R) LAURETH-7 (UNII: Z95S6G8201) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) CYCLOMETHICONE (UNII: NMQ347994Z) JOJOBA OIL (UNII: 724GKU717M) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE 350 (UNII: 2Y53S6ATLU) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83527-1001-1 1 in 1 BOX 06/19/2023 1 30 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 final M015 06/19/2023 Labeler - INDUSTRIAS QUIMICAS INDEPENDENCIA SA (971036108) Registrant - INDUSTRIAS QUIMICAS INDEPENDENCIA SA (971036108) Establishment Name Address ID/FEI Business Operations INDUSTRIAS QUIMICAS INDEPENDENCIA SA 971036108 manufacture(83527-1001)