Label: RAW HEAT- menthol liquid
- NDC Code(s): 55413-2501-1, 55413-2501-2, 55413-2501-3
- 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.
Updated January 30, 2013
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active Ingredient
Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.Close
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.
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.Close
- Inactive Ingredients
Aloe Barbadensis (Aloe) Leaf Gel, SDA 38B, Glycerin, Xanthan Gum, Gaultheria Procumbens (Wintergreen) Leaf Oil, Cinnamomum Cassia (Cassia) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria), Organic Symphytum Officinalis (Comfrey)
RAW Health International, LLCClose
91 Ft. Couch Road-Pittsburgh, PA 15241
- Questions or comments:
Email us at: firstname.lastname@example.org
- PRINCIPAL DISPLAY PANEL – 3 oz. bottle
RAW HEALTH INTERNATIONAL
Warming Pain Reliever
Joint Sprains, Neck/Back Aches,
Pains and Much More…
3 fl OZ / 89 mL
Also Try RAW-ICE for cooling pain relief
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55413-2501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 34.86 g in 1 L Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) glycerin (UNII: PDC6A3C0OX) xanthan gum (UNII: TTV12P4NEE) methyl salicylate (UNII: LAV5U5022Y) chinese cinnamon oil (UNII: A4WO0626T5) 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:55413-2501-1 0.089 L in 1 BOTTLE 2 NDC:55413-2501-2 0.118 L in 1 BOTTLE 3 NDC:55413-2501-3 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(55413-2501)