FDA label 6d81faf7-aa2b-429c-e053-2a91aa0a8bb2

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a0c9a4bc-857b-405a-88f7-7df75e9d6385
SPL ID
6d81faf7-aa2b-429c-e053-2a91aa0a8bb2
Version
2
Effective date
2018-05-31
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:30:36

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

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 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.

warnings and cautions

Drug Facts HOT AND COLD CREAM with LIDOCAINE-RA PAIN RELIEVING CREAM Drug Facts Active Ingredients Lidocaine HCl 4% Menthol 1% Purposes Lidocaine- Topical anesthetic, Menthol- Topical Analgesic 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 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.