Label: 4SPORT SKINCARE ANTI CHAFING- lanolin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 June 25, 2018

If you are a consumer or patient please visit this version.

  • DRUG FACTS

  • Active ingredient:

    Lanolin 40%

  • Purpose

    Skin protectant

  • Uses:

    Temporarily protects the skin and prevents chafing, blisters and irritation.

  • Warnings:

    • For external use only. Do not use on: deep or puncture wounds, animal bites, serious burns
    • When using this product: use only as directed, avoid contact with eyes or mucous membrane

    Stop use and ask a doctor if:

    • Redness occurs, irritation develops, symptoms persist for more than 7 days, or clear up and occur again within a few days
    • If pregnant or breast-feeding ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.
  • Direction:

    Apply to intact skin before any chafing and blister causing activity. Wash off with mild soap.

  • Inactive ingredients:

    Prunus Dulcis (Sweet Almond) Oil, Mineral Oil, Vitis Vinifera (Grape) Seed Oil, Prunus Armeniaca (Apricot) Seed Oil, Retinyl Palmitate, Linoleic Acid, Parfum/Fragrance, Lavandula Angustifolia (Lavender) Essential oil, Limonene, Linalool

  • SPL UNCLASSIFIED SECTION

    protects and nurtures your skin

    The very best from nature

    Made with the best ingredients to protect your skin from chafing, blisters and irritation.

    No chafing

    No blisters

    No irritation

    No pertroleum

    No parabens

    No alcohol

    Manufactured in EU for:

    4SPORT Ltd.,

    Ulica Mirka Vadnova 19,

    4000 Kranj,Slovenia

    www.4sport-skincare.com

    Our anti chafing lotion forms a breathable moisture barrier on the skin, to help fight friction. The formulation makes it easy to apply for all-day protection from skin on skin rubbing, chafing from clothing, friction from shoes, protective gear, and other irritants.

    • Sweat and water resistant
    • Whole body use
    • Non-irritating
    • Airless ecosolution pump bottle container

    Better safe than sorry!

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    4SPORT SKINCARE ANTI CHAFING 
    lanolin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71289-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN40 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71289-101-021 in 1 BOX01/07/2018
    1100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/07/2018
    Labeler - 4sport D.o.o. (644105806)