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NDC 69070-0307-01 EXTRA STRENGTH HUA TUO PAIN RELIEVING 3.1; 2.6 g/100g; g/100g Details
EXTRA STRENGTH HUA TUO PAIN RELIEVING 3.1; 2.6 g/100g; g/100g
EXTRA STRENGTH HUA TUO PAIN RELIEVING is a TRANSDERMAL PLASTER in the HUMAN OTC DRUG category. It is labeled and distributed by Zhejiang Dingtai Pharmaceutical Co., Ltd. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.
Product Information
| NDC | 69070-0307 |
|---|---|
| Product ID | 69070-307_074012ed-36ae-4a6a-94b9-7b5c2d877f91 |
| 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 | EXTRA STRENGTH HUA TUO PAIN RELIEVING |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Camphor and Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PLASTER |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 3.1; 2.6 |
| Active Ingredient Units | g/100g; g/100g |
| Substance Name | CAMPHOR (SYNTHETIC); MENTHOL |
| Labeler Name | Zhejiang Dingtai Pharmaceutical Co., Ltd |
| 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 69070-0307-01 (69070030701)
| NDC Package Code | 69070-307-01 |
|---|---|
| Billing NDC | 69070030701 |
| Package | 1 POUCH in 1 BOX (69070-307-01) / 5 PATCH in 1 POUCH / 1 g in 1 PATCH |
| Marketing Start Date | 2019-04-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9850754b-ac94-4ec6-b75a-8096e5ac9456 Details
SPL UNCLASSIFIED SECTION
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When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ when using for pain of arthritis:
■ pain persists for more than 10 days
■ redness is present
■ in conditions affecting children under 12 years of age
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Inactive ingredients
Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| EXTRA STRENGTH HUA TUO PAIN RELIEVING
camphor and menthol plaster |
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| Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Zhejiang Dingtai Pharmaceutical Co., Ltd | 420598724 | manufacture(69070-307) | |