ANTI-CHAFE STICK PRO SERIES- allantoin stick

Anti-Chafe Stick by

Drug Labeling and Warnings

Anti-Chafe Stick by is a Otc medication manufactured, distributed, or labeled by Mission Product Holdings, Body Blue 2006 inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

PRINCIPAL DISPLAY PANEL

5 hour (TM)

Anti-chafe stick

Pro series

Net. Wt. 1.5 oz (42 G)

INGREDIENTS AND APPEARANCE

ANTI-CHAFE STICK  PRO SERIES
allantoin stick

Product 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)