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NDC 41250-0355-01 Meijer Cold and Hot Pain Relieving 40; 10 mg/g; mg/g Details
Meijer Cold and Hot Pain Relieving 40; 10 mg/g; mg/g
Meijer Cold and Hot Pain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution, INC. The primary component is LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 41250-0355 |
|---|---|
| Product ID | 41250-355_f334ecbb-c950-4051-bdcf-2117e152abbc |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Meijer Cold and Hot Pain Relieving |
| Proprietary Name Suffix | Analgesic |
| Non-Proprietary Name | Lidocaine Hydrochloride and MENTHOL, UNSPECIFIED FORM |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 40; 10 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | Meijer Distribution, INC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 41250-0355-01 (41250035501)
| NDC Package Code | 41250-355-01 |
|---|---|
| Billing NDC | 41250035501 |
| Package | 1 BOTTLE in 1 CARTON (41250-355-01) / 77 g in 1 BOTTLE |
| Marketing Start Date | 2020-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6d356563-9098-4994-8ad8-819a8033a9f4 Details
SPL UNCLASSIFIED SECTION
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 this product
- use only as directed. Read and follow all directions and warnings on this carton.
- rare cases of serious burns have been reported with products of this type
- do not bandage or apply local heat (such as heating pads) to the area of 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
Directions
Inactive ingredients
acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.
PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
INGREDIENTS AND APPEARANCE
| MEIJER COLD AND HOT PAIN RELIEVING
ANALGESIC
lidocaine hydrochloride and menthol, unspecified form cream |
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| Labeler - Meijer Distribution, INC (006959555) |
| Registrant - Garcoa, Inc. (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sigan Industries INC. | 255106239 | MANUFACTURE(41250-355) | |
Revised: 1/2022
Document Id: f334ecbb-c950-4051-bdcf-2117e152abbc
Set id: 6d356563-9098-4994-8ad8-819a8033a9f4
Version: 2
Effective Time: 20220121