NDC | 69027-001-01, 69027-002-01, 69027-003-01, 69027-003-02 |
Set ID | 9c0a20be-da37-4a5d-aceb-76ab906d3f0b |
Category | HUMAN OTC DRUG LABEL |
Packager | Safesha, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
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Warnings
<p class="First"><span style="text-decoration: underline;"><strong>For external use only.</strong></span></p><p class="First"><strong>This product is flammable. Keep away from heat and open flame.</strong><span style="text-decoration: underline;"><strong></strong></span></p><p class="First">If this product comes in contact with eyes, rinse thoroughly with water.</p><p class="First">If irritation persists, stop use and contact a doctor.</p><p class="First">Keep out of reach of children<br></p>
- SPL UNCLASSIFIED SECTION
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- Safesha Moisturizing Hand Sanitizer with Olive Oil (Lavender)
- Safesha Moisturizing Hand Sanitizer with Olive Oil (Sweet Orange)
- Safesha Moisturizing Hand Sanitizer with Olive Oil (Unscented)
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INGREDIENTS AND APPEARANCE
SAFESHA LAVENDER
moisturizing hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69027-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 56.07 in 56.07 Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE (UNII: V5VD430YW9) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) LAVENDER OIL (UNII: ZBP1YXW0H8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69027-001-01 1 in 1 TUBE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2014 SAFESHA SWEET ORANGE
moisturizing hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69027-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 56.07 in 56.07 Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) GLYCERIN (UNII: PDC6A3C0OX) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69027-002-01 1 in 1 TUBE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2014 SAFESHA UNFRAGRANCED
moisturizing hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69027-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 56.07 in 56.07 Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) TOCOPHEROL (UNII: R0ZB2556P8) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69027-003-01 1 in 1 TUBE; Type 0: Not a Combination Product 07/01/2014 2 NDC:69027-003-02 1 in 1 CONTAINER; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2014 Labeler - Safesha, LLC (079975761) Registrant - Safesha, LLC (079975761) Establishment Name Address ID/FEI Business Operations Kapra Cosmetics 809506223 manufacture(69027-001, 69027-002, 69027-003)