Label: HOT AND COLD WITH LIDOCAINE-RA PAIN RELIEVING- lidocaine hcl and menthol cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 71301-003-24 - Packager: Yash Pharmaceuticals
- 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 May 25, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Drug Facts
HOT AND COLD CREAM with LIDOCAINE-RA
PAIN RELIEVING CREAM
Drug FactsActive Ingredients
Lidocaine HCl 4%
Menthol 1%Purposes
Lidocaine- Topical anesthetic,
Menthol- Topical AnalgesicWARNINGS
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 one week without consulting a doctor
WHEN USING SECTION
- Use only as directed. Read and follow all directions and warnings on this label
- rare cases of serious burns have been reported with products of this type
- do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
- avoid contact with eyes and mucous membranes
- a transient burning sensation may occur upon application but generally disappears in several days
If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION adults and children over 12 years:
- apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
- AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
children 12 years or younger: ask a doctor
INACTIVE INGREDIENT SECTION Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly
Keep Carton As It Contains Important Information
Close cap tightly between uses. - Outer Label
- Outer Label
-
INGREDIENTS AND APPEARANCE
HOT AND COLD WITH LIDOCAINE-RA PAIN RELIEVING
lidocaine hcl and menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71301-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.4 in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-2 (UNII: 7H8VAM7778) CETYL ALCOHOL (UNII: 936JST6JCN) CETETH-20 PHOSPHATE (UNII: 921FTA1500) EDETATE DISODIUM (UNII: 7FLD91C86K) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBIC ACID (UNII: X045WJ989B) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71301-003-24 192 in 1 CASE 05/25/2017 1 76.5 g in 1 BOTTLE; 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 part348 05/25/2017 Labeler - Yash Pharmaceuticals (871409551) Establishment Name Address ID/FEI Business Operations Yash Pharmaceuticals 871409551 manufacture(71301-003) Establishment Name Address ID/FEI Business Operations VELOCITY PHARMA 962198409 repack(71301-003) , relabel(71301-003)
