Label: RAW ICE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69381-2500-1, 69381-2500-2, 69381-2500-3 - Packager: Rescue Dog Health
- 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 December 18, 2014
If you are a consumer or patient please visit this version.
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- 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. Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application. Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs. If pregnant or breast feeding ask a health care professional before use. Store at room temperature.
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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, Cinnamomum Camphora (Camphor) Bark Oil, Dehydroxanthan Gum, Glycerin, Mentha Piperita (Peppermint) Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinale (Comfrey), SDA 38B, Xanthan Gum
Rescue Health, LLC
Bentonville, AR 72712www.rawhealthintl.com
Ph: 1-888-RAW-HLTH - Questions or comments:
- Principal Display Panel - Bottle Label
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INGREDIENTS AND APPEARANCE
RAW ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69381-2500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 3.5 mg 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:69381-2500-1 0.089 L in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69381-2500-2 0.118 L in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69381-2500-3 0.946 L in 1 BOTTLE; 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 part348 12/18/2014 Labeler - Rescue Dog Health (079558153) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(69381-2500)
