Label: GENTLE HANDS SANITIZER CALMING CITRUS- hand sanitizer spray calming citrus liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 74299-281-01, 74299-281-02, 74299-281-03 - Packager: Southern Distilling Company 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 September 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use(s)
- Warnings
- Do Not Use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- Gentle Hands Sanitizer Spray Calming Citrus 2 oz 59 mL
- Gentle Hands Sanitizer Spray Calming Citrus 3.4 oz 100 mL
- Gentle Hands Sanitizer Spray Calming Citrus 32 oz 946.35 mL
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INGREDIENTS AND APPEARANCE
GENTLE HANDS SANITIZER CALMING CITRUS
hand sanitizer spray calming citrus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74299-281 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BERGAMOT OIL (UNII: 39W1PKE3JI) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74299-281-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2020 2 NDC:74299-281-02 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/01/2020 3 NDC:74299-281-03 946.35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - Southern Distilling Company LLC (046275910) Establishment Name Address ID/FEI Business Operations Southern Distilling Company LLC 046275910 manufacture(74299-281)
