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NDC 72189-0286-04 CALYPXO PAIN RELIEF 3; 10 g/100g; g/100g Details
CALYPXO PAIN RELIEF 3; 10 g/100g; g/100g
CALYPXO PAIN RELIEF is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRX. The primary component is MENTHOL; METHYL SALICYLATE.
Product Information
NDC | 72189-0286 |
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Product ID | 72189-286_cf424c1c-f0b4-d903-e053-2995a90afd69 |
Associated GPIs | 90809902603700 |
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 | CALYPXO PAIN RELIEF |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | methyl salicylate, menthol cream |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 3; 10 |
Active Ingredient Units | g/100g; g/100g |
Substance Name | MENTHOL; METHYL SALICYLATE |
Labeler Name | DirectRX |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 72189-0286-04 (72189028604)
NDC Package Code | 72189-286-04 |
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Billing NDC | 72189028604 |
Package | 113 g in 1 BOTTLE (72189-286-04) |
Marketing Start Date | 2021-10-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cf424c1c-f0b3-d903-e053-2995a90afd69 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
For external use only.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or cover treated areas.
Do not use with heating pad.
Do not apply to open wounds or damages skin.
A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.
If symptoms persist for more than seven days, discontinue use and consult physician.
Keep out of reach of children. If swallowed, consult physician.
If pregnant or breast feeding, contact physician prior to use.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
CALYPXO PAIN RELIEF
methyl salicylate, menthol cream cream |
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Labeler - DirectRX (079254320) |
Registrant - DirectRX (079254320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
DirectRX | 079254320 | relabel(72189-286) |
Revised: 10/2021
Document Id: cf424c1c-f0b4-d903-e053-2995a90afd69
Set id: cf424c1c-f0b3-d903-e053-2995a90afd69
Version: 1
Effective Time: 20211026