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BETTER NATURE PAIN RELIEF BALMX- Capsaicin Cream

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BETTER NATURE PAIN RELIEF BALMX- Capsaicin Cream BETTER NATURE PAIN RELIEF BALMX- capsaicin cream Better Nature Pty Ltd 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. ---------- Active Ingredients Capsicum Oleoresin 0.25% (Containing Capsaicin 0.1%) Purpose Capsicum Oleoresin 0.25%................Topical Analgesic (Containing Capsaicin 0.1%) Uses Temporarily relieves minor pain associated with: arthritis simple backache strains sprains bruises Warnings For external use only Do not use if you are allergic to salicylates (including aspirin) unless directed by doctor skin is infected or damaged excessive irritation develops 12 years of age or under. When using this product use only as directed avoid contact with eyes or mucous membranes do not apply to wounds, damaged, broken or irritated skin do not bandage tightly or use a heating pad. Stop and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within days redness develops. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. If swallowed, contact a physician or contact a Poison Control Center immediately. Directions Adults and children 13 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 13 years of age: consult a physician. Other information Store between 15C (59F) and 30C(86F) with the cap closed Notice: Colour may vary. Inactive ingredients arnica oil, beeswax, black pepper oil, cetostearyl alcohol, d-alpha-tocopherol (vitamin e), eucalyptus oil, glycerin, grapefruit oil, jojoba oil, lavander oil, lecithin, macadamia oil, olive oil, orange oil, rice bran oil, rosemary oil, soybean oil, st. johns' wort oil, sunflower oil and wintergreen oil. Questions or comments? Call toll free 1-800-720-5801 Adverse Event Reporting contact 1-800-222-1222 Better Nature Better Nature Pain Relief BalmX 100% Naturally Sourced With Capsicum Oleoresin WARMING Australian Made Net Wt. 2.64oz (75g) BETTER NATURE PAIN RELIEF BALMX capsaicin cream Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:73454-0 0 1 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM) CAPSAICIN 1 mg in 1 g Inactive Ingredients Ingredient Name Strength LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2) SO YBEAN O IL (UNII: 241ATL177A) HYPERICUM O IL (UNII: OZU2FC70 HY) SUNFLO WER O IL (UNII: 3W1JG79 5YI) GRAPEFRUIT O IL (UNII: YR377U58 W9 ) O RANGE O IL (UNII: AKN3KSD11B) JO JO BA O IL (UNII: 724GKU717M) LAVENDER O IL (UNII: ZBP1YXW0 H8 ) YELLO W WAX (UNII: 2ZA36 H0 S2V) .ALPHA.-TO CO PHERO L, D- (UNII: N9 PR349 0 H9 ) EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) GLYCERIN (UNII: PDC6 A3C0 OX) MACADAMIA O IL (UNII: 5156 10 SU8 C) O LIVE O IL (UNII: 6 UYK2W1W1E) RICE BRAN O IL (UNII: LZO6 K150 6 A) RO SEMARY O IL (UNII: 8 LGU7VM39 3) ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ) METHYL SALICYLATE (UNII: LAV5U50 22Y) BLACK PEPPER O IL (UNII: U17J8 4S19 Z) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73454-0 0 1-75 1 in 1 CARTON 12/0 2/20 19 1 75 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 12/0 2/20 19 Labeler - Better Nature Pty Ltd (745189065) Establishment Name Addre ss ID/FEI Busine ss Ope rations WILD CHILD W A PTY LTD 7446 6 0 6 9 2 manufacture(73454-0 0 1) Revised: 12/2019 Better Nature Pty Ltd.
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