Label: WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON- lidocaine 5% solution
- NDC Code(s): 83833-101-03
- Packager: OTC PHARM LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purporse
- Use
-
Warnings
For external use only
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than week without consulting a doctor
When using this product:
- use cnly as directed. Read and follow all directions and warnings on this carton
- do not allow contact with the eyes and mucous membranes
- do not bandage or apply a local heat (such as heating pads) to the area of use
Stop use and aska doctor if
- condition worsens
- skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
- symptoms persist for more than 7 days or clear up and occur again within a days
Flammable
- keep away from fire or flame
If pregnant or breast freding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingrediants
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WELAHEAD BY WELMATE LIDOCAINE 5% ROLL-ON
lidocaine 5% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83833-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 g in 100 mL Inactive Ingredients Ingredient Name Strength CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM CARBONATE (UNII: BQN1B9B9HA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83833-101-03 90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 12/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 12/01/2023 Labeler - OTC PHARM LLC (119131224) Registrant - OTC PHARM LLC (119131224)