ANTI-CHAFE STICK PRO SERIES- allantoin stick 
Mission Product Holdings

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.

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Anti-chafe Stick Pro Series

Active ingredients               Purpose

Allantoin (0.5%)                Skin protectant




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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

Keep out of reach of children

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

Directions: apply as needed


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.


5 hour (TM)

Anti-chafe stick

Pro series


Net. Wt. 1.5 oz (42 G)




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ANTI-CHAFE STICK  PRO SERIES
allantoin stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76347-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COTTONSEED OIL 
DICAPRYLYL CARBONATE 
CYCLOMETHICONE 5 
STEARYL ALCOHOL 
CANDELILLA WAX 
CERESIN 
TALC 
SILICON DIOXIDE 
DIMETHICONE 
SHEA BUTTER 
VITAMIN A PALMITATE 
PYRIDOXINE HYDROCHLORIDE 
SODIUM ASCORBYL PHOSPHATE 
CHOLECALCIFEROL 
ALOE VERA LEAF 
POMEGRANATE SEED OIL  
CRANBERRY SEED OIL 
SAFFLOWER OIL 
LYCIUM BARBARUM FRUIT 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76347-125-021 in 1 BLISTER PACK
1NDC:76347-125-0142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/26/2011
Labeler - Mission Product Holdings (808672120)
Registrant - Mission Product Holdings (808672120)
Establishment
NameAddressID/FEIBusiness Operations
Body Blue 2006 inc243094112manufacture(76347-125)

Revised: 2/2013
Document Id: 0a3a1775-46a6-4d6c-a6e9-c0122165240f
Set id: 93bc4dfe-d5c0-40da-8de6-3bd3449c2072
Version: 15
Effective Time: 20130212
 
Mission Product Holdings