Label: ANTI-CHAFE STICK PRO SERIES- allantoin stick
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Contains inactivated NDC Code(s)
NDC Code(s): 76347-125-01, 76347-125-02 - Packager: Mission Product Holdings
- Category: HUMAN OTC DRUG LABEL
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 February 12, 2013
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ACTIVE INGREDIENT
Active ingredients Purpose
Allantoin (0.5%) Skin protectant
Uses: Helps Prevent and temporarily relieve chafed, chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
Temporarily protects minor cuts, scrapes , burns
Stop use and ask a doctor if
Conditions worsens
symptoms last more than 7 days or clear up and occur again within a few days
Warnings: For external use only
When using this product: do not get into eyes
Do not use on: deep puncture wounds, Animal bites , Serious burns
If swallowed,get medical or contact Poison Control Center
Inactive ingredients: Glycine soja (soybean) oil, hydrogenated cottonseed oil, dicaprylyl carbonate, beeswax, cyclopentasiloxane, stearyl alcohol, Euphorbia Cerifera (candelilla) wax, ozokerite, talc, silica, dimethicone, butyrospermum parkii (shea butter), tocopheryl acetate, retinyl palmitate, pyridoxine HCL, Sodium ascorbyl phosphate, cholecalciferol, zea mays (corn) oil, phytonidone, aloe barbadensis leaf extract, euterpe oleracea seed oil, punica granatum seed oil, vaccinium macrocarpon (cranberry) seed oil, carthamus tinctorius (safflower) seed oil, lycium barbarum fruit extract.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-CHAFE STICK PRO SERIES
allantoin stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76347-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CANDELILLA WAX (UNII: WL0328HX19) CERESIN (UNII: Q1LS2UJO3A) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) SHEA BUTTER (UNII: K49155WL9Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CHOLECALCIFEROL (UNII: 1C6V77QF41) ALOE VERA LEAF (UNII: ZY81Z83H0X) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) SAFFLOWER OIL (UNII: 65UEH262IS) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76347-125-02 1 in 1 BLISTER PACK 1 NDC:76347-125-01 42 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/26/2011 Labeler - Mission Product Holdings (808672120) Registrant - Mission Product Holdings (808672120) Establishment Name Address ID/FEI Business Operations Body Blue 2006 inc 243094112 manufacture(76347-125)
