Anti-chafe Stick Pro Series

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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Active ingredients Purpose

Allantoin (0.5%) Skin protectant

image of secondary back label

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)

ANTI-CHAFE STICK PRO SERIES
allantoin stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76347-125
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (ALLANTOIN)	ALLANTOIN	0.5 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
PUNICA GRANATUM SEED OIL
CRANBERRY SEED OIL
SAFFLOWER OIL
LYCIUM BARBARUM FRUIT

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76347-125-02	1 TUBE ( TUBE) in 1 BLISTER PACK	contains a TUBE (76347-125-01)
1	NDC:76347-125-01	42 g in 1 TUBE	This package is contained within the BLISTER PACK (76347-125-02)

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	Operations
Body Blue 2006 inc		243094112	manufacture

Revised: 09/2011 Mission Product Holdings