Label: RAW ICE- menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55413-2500-1, 55413-2500-2, 55413-2500-3 - Packager: Raw Health International, 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 January 30, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only. Flammable. Keep away from open flame or extreme heat.
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly.
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Directions
For adults and children 6 years of age and older: Shake well. Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.
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Inactive Ingredients
Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Mentha Piperita (Peppermint) Oil, Xanthan Gum, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinalis (Comfrey)
RAW Health International, LLC
91 Ft. Couch Road-Pittsburgh, PA 15241
www.rawhealthintl.com
Ph: 1-888-RAW-HLTH - Questions or comments:
- PRINCIPAL DISPLAY PANEL – 3 oz. bottle
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INGREDIENTS AND APPEARANCE
RAW ICE
menthol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55413-2500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 34.79 g in 1 L Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) glycerin (UNII: PDC6A3C0OX) peppermint oil (UNII: AV092KU4JH) xanthan gum (UNII: TTV12P4NEE) camphor oil (UNII: 75IZZ8Y727) matricaria recutita (UNII: G0R4UBI2ZZ) symphytum uplandicum leaf (UNII: D05HXK6R3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55413-2500-1 0.089 L in 1 BOTTLE 2 NDC:55413-2500-2 0.118 L in 1 BOTTLE 3 NDC:55413-2500-3 0.004 L in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/15/2013 Labeler - Raw Health International, LLC (014982454) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(55413-2500)