PURESPA HAND SANITIZER MAGNOLIA WILDFLOWER- alcohol spray
Shalom International Corp
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Purespa Hand Sanitizer Spray Magnolia Wildflower
Active Ingredients
Alcohol Denat. 60%
Uses
Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.
Warnings
-
Flamable. Keep away from fire or flame.
-
For external use only.
When using this product
do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use & ask a doctor
if irritation or rash appears & lasts.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply enough product to thoroughly cover hands.
- Rub hands together briskly until dry.
Other Information
- Do not store above 110°F (43°C).
- May discolor certain fabrics or surfaces.
Inactive Ingredients
- Water / Aqua, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopheryl Acetate, FD&C Yellow 5
Package Labeling:
PURESPA HAND SANITIZER MAGNOLIA WILDFLOWER
alcohol spray |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 73025-055 |
| Route of Administration | TOPICAL |
|
| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) | ALCOHOL | 0.6 mL in 1 mL |
|
| Inactive Ingredients |
| Ingredient Name | Strength |
| WATER (UNII: 059QF0KO0R) | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) | |
| CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) | |
| DMDM HYDANTOIN (UNII: BYR0546TOW) | |
| SODIUM HYDROXIDE (UNII: 55X04QC32I) | |
| .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) | |
| FD&C YELLOW NO. 5 (UNII: I753WB2F1M) | |
|
|
| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 73025-055-60 | 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product | 06/01/2020 | 12/31/2021 |
|
|
| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part333E | 06/01/2020 | 12/31/2021 |
|
| Labeler - Shalom International Corp
(001384825)
|