Label: SAFESHA LAVENDER- moisturizing hand sanitizer liquid
SAFESHA SWEET ORANGE- moisturizing hand sanitizer liquid
SAFESHA UNFRAGRANCED- moisturizing hand sanitizer liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69027-001-01, 69027-002-01, 69027-003-01, 69027-003-02 - Packager: Safesha, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 27, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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)
