NDC | 52763-601-20 |
Set ID | 06bcbe4f-faae-43dc-941d-9e0e2b9a7572 |
Category | HUMAN OTC DRUG LABEL |
Packager | Golden Touch LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- Active ingredient
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
-
Warnings
For external use only
When using this product- Avoid contact with the eyes
- Do not put in rectum
- Do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- Symptoms clear up and return within a few days
- rectal bleading occurs
- redness irritation swelling pain or other symptoms develop or increase
-
Directions
- Adults when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- Apply externally to the affected area up to 6 times daily.
- Children under 12 years of age: consult a doctor
- Inactive ingredients
- Packaging
-
INGREDIENTS AND APPEARANCE
SIMPLY NUMB ENDURE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52763-601 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL OLEATE (UNII: 4PC054V79P) ALCOHOL (UNII: 3K9958V90M) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52763-601-20 120 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/08/2014 Labeler - Golden Touch LLC (194284147) Establishment Name Address ID/FEI Business Operations Golden Touch LLC 194284147 manufacture(52763-601)