Label: PURE PETROLEUM ALOE WITH VITAMIN E OIL- white petroleum jelly

  • NDC Code(s): 52920-127-35, 52920-127-36, 52920-127-37, 52920-127-38, view more
    52920-127-39, 52920-127-40
  • Packager: Singhfam Corporation
  • 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 November 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP (99.9 %)

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For the temporary protection of minor cuts, scrapes, burns and sunburn.

    • Helps to temporarily protect chafed, chapped, cracked  or windburned skin and lips.
  • WARNINGS

    Warnings

    For External Use Only.

    Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

    When using this product avoid contact with eyes.

    Stop use and ask doctor if conditon worsens or does not improve within 7 days.

    Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product liberally, as often as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Vera Extract, Vitamin E and Fragrance

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Pure Petroleum Aloe with Vitamin E Oil Jelly

    Net Wt. 4 oz. (113g)

    label

  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM  ALOE WITH VITAMIN E OIL
    white petroleum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-127
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52920-127-35100 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    2NDC:52920-127-36113 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    3NDC:52920-127-37170 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    4NDC:52920-127-38226 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    5NDC:52920-127-39283 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    6NDC:52920-127-40368 g in 1 JAR; Type 0: Not a Combination Product11/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/10/2015
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52920-127)
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