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NDC 64596-0388-88 Hand Sanitizer 67 mL/100mL Details
Hand Sanitizer 67 mL/100mL
Hand Sanitizer is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Gilchrist & Soames. The primary component is ALCOHOL.
Product Information
| NDC | 64596-0388 |
|---|---|
| Product ID | 64596-388_aee86022-c867-ebb0-e053-2995a90aedcd |
| 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 | Hand Sanitizer |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ALCOHOL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 67 |
| Active Ingredient Units | mL/100mL |
| Substance Name | ALCOHOL |
| Labeler Name | Gilchrist & Soames |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part333A |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 64596-0388-88 (64596038888)
| NDC Package Code | 64596-388-88 |
|---|---|
| Billing NDC | 64596038888 |
| Package | 3780 mL in 1 BOTTLE, PLASTIC (64596-388-88) |
| Marketing Start Date | 2020-09-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL aee86022-c868-ebb0-e053-2995a90aedcd Details
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Use
SPL UNCLASSIFIED SECTION
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
INGREDIENTS AND APPEARANCE
| HAND SANITIZER
alcohol solution |
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| Labeler - Gilchrist & Soames (052683856) |
| Registrant - Gilchrist & Soames (052683856) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Gilchrist & Soames | 052683856 | manufacture(64596-388) | |