Label: SOLE WIPE- 70% ethanal alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81813-507-01 - Packager: Soul Wipe, Inc.
- 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 November 27, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Flammable. Keep away from sources of heat, 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 and ask a doctor if irritation or redness develops and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- Crown Chakra
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INGREDIENTS AND APPEARANCE
SOLE WIPE
70% ethanal alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81813-507 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 BURSERA GRAVEOLENS FRUIT OIL (UNII: R0U10T34I4) 0.1 mL in 100 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) 25 mL in 100 mL CHAMOMILE (UNII: FGL3685T2X) 0.005 mL in 100 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.005 mL in 100 mL GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.005 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.005 mL in 100 mL WATER (UNII: 059QF0KO0R) VETIVER OIL (UNII: 9M9P32M01L) 0.1 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81813-507-01 500 mL in 1 JAR; Type 0: Not a Combination Product 05/11/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/11/2021 Labeler - Soul Wipe, Inc. (101974567) Establishment Name Address ID/FEI Business Operations Prime Matter Labs West, LLC 118568102 manufacture(81813-507)
