Label: HEALTH SMART ALOE VERA PETROLEUM- white petroleum jelly

  • NDC Code(s): 52862-012-01, 52862-012-14, 52862-012-19, 52862-012-20, view more
    52862-012-21, 52862-012-22, 52862-012-23, 52862-012-24, 52862-012-25, 52862-012-26
  • Packager: Home Smart Products
  • 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 August 11, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    White Petroleum (99.9%)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    • Temporarily protects minor cuts, scrapes or burns.

    • Temporarily protects and helps relieve chapped or cracked skin and lips.

    • Helps protect from the drying effects of wind and cold weather.

  • WARNINGS

    Warning:

    For External Use Only.

  • DO NOT USE

    Do not use on:

    • deep or puncture wounds
    • lacerations or infections
    • serious burns
    • animal bites
  • STOP USE

    Stop use and ask doctor

    • if condition does not improve or lasts more than 7 days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed get medical help or contact Poison Control Center right away.
    • if redness or swelling developes, consult a physician promptly.
  • DOSAGE & ADMINISTRATION

    Directions:

    Apply as often as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    None.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART ALOE VERA PETROLEUM JELLY

    NET WT. 8OZ. (226G)

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART ALOE VERA PETROLEUM 
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-012-1950 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    2NDC:52862-012-20100 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    3NDC:52862-012-14113 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    4NDC:52862-012-21170 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    5NDC:52862-012-01226 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    6NDC:52862-012-22283 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    7NDC:52862-012-23368 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    8NDC:52862-012-24425 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    9NDC:52862-012-25450 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    10NDC:52862-012-26500 g in 1 BOTTLE; Type 0: Not a Combination Product07/28/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/28/2013
    Labeler - Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-012)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!