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NDC 00573-2890-02 Preparation H Rapid Relief 50; 2.5 mg/g; mg/g Details
Preparation H Rapid Relief 50; 2.5 mg/g; mg/g
Preparation H Rapid Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00573-2890 |
|---|---|
| Product ID | 0573-2890_27db1d58-4609-4a80-af2f-9e36f10482e1 |
| 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 | Preparation H Rapid Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine, Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | TOPICAL |
| Active Ingredient Strength | 50; 2.5 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00573-2890-02 (00573289002)
| NDC Package Code | 0573-2890-02 |
|---|---|
| Billing NDC | 00573289002 |
| Package | 127.6 g in 1 CANISTER (0573-2890-02) |
| Marketing Start Date | 2022-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 27db1d58-4609-4a80-af2f-9e36f10482e1 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
For external use only
Flammable: Do not use while smoking or near heat or flame
Ask a doctor before use if you have
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- heart disease
- •
- high blood pressure
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- thyroid disease
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- diabetes
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- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
When using this product
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put this product into the rectum by using fingers or any mechanical device or applicator
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- Warning - avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
- •
- Warning - use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
SPL UNCLASSIFIED SECTION
Directions
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- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
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- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
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- Shake well before using
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- Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
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- Apply externally to the affected area up to 4 times daily
- •
- Children under 12 years of age: consult a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Additional Information
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| PREPARATION H RAPID RELIEF
lidocaine, phenylephrine hydrochloride spray |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
Revised: 11/2021
Document Id: 27db1d58-4609-4a80-af2f-9e36f10482e1
Set id: 27db1d58-4609-4a80-af2f-9e36f10482e1
Version: 1
Effective Time: 20211112