Label: PAIN RELIEF CAFFEINE AND HEMP (caffeine (coffeinum) 6x, hemp extract- cannabis sativa 2x spray
- NDC Code(s): 73002-321-01
- Packager: Green Earth Health Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Updated August 27, 2020
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- Active Ingredients Purpose
- KEEP OUT OF REACH OF CHILDREN
• Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
• If symptoms persist or worsen, stop using this product and consult physician.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If pregnant or breastfeeding or if diagnosed with psychiatric or mood disorder, seek medical advice before use.
• Keep out of reach of children.
Directions For Use:
- Do not use if tamperproof cover is missing
- Press down 4 times to prime the pump.
- Spray 2 times directly into the mouth or under the tongue.
- Start using 3 times per day. Use as needed thereafter to relieve discomfort.
- Allow several days for product to take maximum effect.
- Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
- Other Information:
- Inactive Ingredients:
- Product label
INGREDIENTS AND APPEARANCE
PAIN RELIEF CAFFEINE AND HEMP
caffeine (coffeinum) 6x, hemp extract (cannabis sativa) 2x spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73002-321 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE CITRATE 6 [hp_X] in 1 mL CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW) TEA LEAF (UNII: GH42T47V24) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBIC ACID (UNII: PQ6CK8PD0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73002-321-01 28 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/19/2019 Labeler - Green Earth Health Inc. (116983264) Establishment Name Address ID/FEI Business Operations Maitland Labs of Central Florida 080974960 manufacture(73002-321) Establishment Name Address ID/FEI Business Operations Organics Corporation of America DBA Ambix Laboratories 061061164 manufacture(73002-321)