Label: RAINING ROSE ANTISEPTIC HAND SANITIZER - alcohol spray
- NDC Code(s): 65692-1001-8
- Packager: Raining Rose, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Ethyl Alcohol 62%
- INDICATIONS & USAGE
For hand washing to decrease bacteria on the skin
Recommended for repeated use
Flammable. Keep away from heat and flame. Close
For external use only. Close
- WHEN USING
When using this product
Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Close
- STOP USE
if irritation and redness develops. If condition persists for more than 72 hours consult a doctor. Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away. Close
- DOSAGE & ADMINISTRATION
Wet hands thoroughly with product and allow to dry without wiping
Children under 6 of age should be supervised when using this product.
Not recommended for infants.
Do not store above 105 degrees F.
May discolor some fabrics. Close
- INACTIVE INGREDIENT
Water, glycerin, propylene glycol,
aloe barbadenis leaf Juice, fragranceClose
- INGREDIENTS AND APPEARANCE
RAINING ROSE ANTISEPTIC HAND SANITIZER
ethyl alcohol spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-1001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-1001-8 8 mL in 1 VIAL, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/30/2012 Labeler - Raining Rose, Inc. (083819404)