ZELLULISAN- arnica montana root, ledum palustre twig, toxicodendron pubescens shoot, sulfur, horse chestnut, betula pendula leaf, hedera helix flowering twig, and melilotus officinalis top ointment PEKANA Naturheilmittel GmbH 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. ------ZELLULISAN™ Drug facts
Active ingredients Aesculus hippocastanum 4X Arnica montana 8X Betula pendula e foliis (Betula 8X folium) Hedera helix 6X Ledum palustre 3X Melilotus officinalis 4X Toxicodendron quercifolium 8X (Rhus toxicodendron) Sulfur 15X
Selected ingredients prepared by spagyric processes.
Uses 1 For relief of minor tendinitis and inflammation
1 Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. These "Uses" have not been evaluated by the Food and Drug Administration. With severe forms of this disease, a clinically proven therapy is indicated.
Warnings For external use only. Do not use on open wounds! If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use. Keep out of the reach of children.
Directions Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.
Other information Protect from light and heat.
Tamper Evident Do not use this product if tamper evident strip is broken or removed from base of cap.
Inactive ingredients Purified water, cetylstearyl alcohol, glycerol, synthetic cetaceum, triglycerides. Manufactured by: PEKANA® GmbH D-88353 Kisslegg Distributed by: BioResource Inc. Cotati, CA 94931
PRINCIPAL DISPLAY PANEL - 100 g Tube Box PEKANA® ZELLULISAN™ Homeopathic Ointment For relief of minor tendinitis and inflammation 3.5 OZ 100 g
ZELLULISAN arnica montana root, ledum palustre twig, toxicodendron pubescens shoot, sulfur, horse chestnut, betula pendula leaf, hedera helix flowering twig, and melilotus officinalis top ointment
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:59 46 9 -138 Route of Administration CUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MO NTANA RO O T (UNII: MUE8 Y11327) (ARNICA MONTANA ROOT - 8 [hp_X] ARNICA MONTANA ROOT UNII:MUE8 Y11327) in 10 0 g RHO DO DENDRO N TO MENTO SUM LEAFY TWIG (UNII: 8 77L0 1IZ0 P) RHODODENDRON 3 [hp_X] (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:8 77L0 1IZ0 P) TOMENTOSUM LEAFY TWIG in 10 0 g TO XICO DENDRO N PUBESCENS SHO O T (UNII: 46 PYZ1F8 2M) (TOXICODENDRON TOXICODENDRON 8 [hp_X] PUBESCENS SHOOT - UNII:46 PYZ1F8 2M) PUBESCENS SHOOT in 10 0 g 15 [hp_X] SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 ) SULFUR in 10 0 g 4 [hp_X] HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ) (HORSE CHESTNUT - UNII:3C18 L6 RJAZ) HORSE CHESTNUT in 10 0 g BETULA PENDULA LEAF (UNII: 5HW39 H9 KDH) (BETULA PENDULA LEAF - 8 [hp_X] BETULA PENDULA LEAF UNII:5HW39 H9 KDH) in 10 0 g HEDERA HELIX FLO WERING TWIG (UNII: 3D10 KUA6 BM) (HEDERA HELIX HEDERA HELIX FLOWERING 6 [hp_X] FLOWERING TWIG - UNII:3D10 KUA6 BM) TWIG in 10 0 g MELILO TUS O FFICINALIS TO P (UNII: GM6 P0 2J2DX) (MELILOTUS OFFICINALIS TOP MELILOTUS OFFICINALIS 4 [hp_X] - UNII:GM6 P0 2J2DX) TOP in 10 0 g
Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U) CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) SPERMACETI (UNII: P8 6 KHA8 V3K) GLYCERIN (UNII: PDC6 A3C0 OX) WATER (UNII: 0 59 QF0 KO0 R) ALCO HO L (UNII: 3K9 9 58 V9 0 M)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59 46 9 -138 -40 1 in 1 BOX 12/11/20 0 8 1 10 0 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct 2 NDC:59 46 9 -138 -30 1 in 1 BOX 12/11/20 0 8 2 30 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 UNAPPROVED HOMEOPATHIC 12/11/20 0 8
Labeler - PEKANA Naturheilmittel GmbH (320344542)
Establishment Name Addre ss ID/FEI Busine ss Ope rations PEKANA Naturheilmittel GmbH 320 344542 MANUFACTURE(59 46 9 -138 )
Revised: 12/2019 PEKANA Naturheilmittel GmbH