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NDC 70000-0169-01 Leader Maximum Strength Pain Relieving 100 mg/g Details
Leader Maximum Strength Pain Relieving 100 mg/g
Leader Maximum Strength Pain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is TROLAMINE SALICYLATE.
Product Information
NDC | 70000-0169 |
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Product ID | 70000-0169_872dde69-3513-4be6-95f4-f411373ab41e |
Associated GPIs | 90800080103720 |
GCN Sequence Number | 006137 |
GCN Sequence Number Description | trolamine salicylate CREAM (G) 10 % TOPICAL |
HIC3 | L6A |
HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
GCN | 24090 |
HICL Sequence Number | 002637 |
HICL Sequence Number Description | TROLAMINE SALICYLATE |
Brand/Generic | Generic |
Proprietary Name | Leader Maximum Strength Pain Relieving |
Proprietary Name Suffix | Analgesic |
Non-Proprietary Name | Trolamine Salicylate |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/g |
Substance Name | TROLAMINE SALICYLATE |
Labeler Name | Cardinal Health, 110 dba LEADER |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 70000-0169-01 (70000016901)
NDC Package Code | 70000-0169-1 |
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Billing NDC | 70000016901 |
Package | 1 TUBE in 1 CARTON (70000-0169-1) / 85 g in 1 TUBE |
Marketing Start Date | 2017-08-31 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.03299 |
Pricing Unit | GM |
Effective Date | 2024-02-21 |
NDC Description | PAIN RELIEVING 10% CREAM |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 0ffad817-e64c-40c5-a281-53ed0a3f7529 Details
Uses
Warnings
For external use only
Allergy alert!
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product
- ♦
- use only as directed. Read an follow all directions and warnings on this label
- ♦
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- ♦
- avoid contact with eyes and mucous membranes
- ♦
- do not apply to wounds or damaged, broken or irritated skin
- ♦
- do not use at the same time as other topical analgesics
Stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
- ♦
- redness is present
- ♦
- irritation develops
Directions
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
MAXIMUM STRENGTH
NDC 70000-0169-1
Pain Relieving Cream
Trolamine Salicylate, 10%
Topical Analgesic Rub
Temporary Relief of Minor Muscle Aches and Pains
Associated with Arthritis, Simple Backache or Sprains
Fast Acting • Odor Free • With Aloe
COMPARE TO
ASPERCREME®
MAXIMUM STRENGTH
active ingredients*
100% Money Back Guarantee
NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE
LEADER MAXIMUM STRENGTH PAIN RELIEVING
ANALGESIC
trolamine salicylate cream |
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Labeler - Cardinal Health, 110 dba LEADER (063997360) |
Registrant - Garcoa, Inc (036464697) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Garcoa, Inc | 036464697 | MANUFACTURE(70000-0169) |