Label: RAREESSENCE HAND SANITIZER- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78035-001-01, 78035-001-02, 78035-001-03, 78035-001-04, view more78035-001-05, 78035-001-06 - Packager: rareESSENCE, 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 June 2, 2020
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
rareESSENCE AROMATHERAPY
Spray It Away (TM)
Hand Sanitizer
Alcohol Antiseptic 70%
With Pure essential oils
Lavender orange
Feel good. Do good.
For every bottle you purchase, we will donate a portion of the proceeds to U.S. food shelves.
With 100% Pure Essential Oils
No Synthetic Frangrances
No Phthalates
No Parabens
Reduceds Germs that can potentially cause disease
Washing hands with soap and warm water remains the best way to remove germs. For use when souap and water are not available.
Made in USA
rareEssence, LLC
Minneapolis, MN 55344
www.rareEssenccearomatherapy.com
xx oz (zzzmL) NDC 78035-001-xx
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INGREDIENTS AND APPEARANCE
RAREESSENCE HAND SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78035-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ORANGE OIL (UNII: AKN3KSD11B) LAVENDER OIL (UNII: ZBP1YXW0H8) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL (UNII: I9GRO824LL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78035-001-03 48 in 1 CARTON 06/02/2020 1 NDC:78035-001-02 12 in 1 CASE 1 NDC:78035-001-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:78035-001-06 48 in 1 CARTON 06/02/2020 2 NDC:78035-001-05 12 in 1 CASE 2 NDC:78035-001-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/02/2020 Labeler - rareESSENCE, LLC (011585557) Registrant - rareESSENCE, LLC (011585557) Establishment Name Address ID/FEI Business Operations Diversified Manufacturing Corporation 185073996 manufacture(78035-001) , pack(78035-001) , repack(78035-001) , label(78035-001)