Label: PURE PETROLEUM- petrolatum jelly

  • NDC Code(s): 52920-121-01, 52920-121-16, 52920-121-17, 52920-121-18, view more
    52920-121-19, 52920-121-20, 52920-121-21, 52920-121-22, 52920-121-23, 52920-121-24
  • Packager: Singhfam Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • ACTIVE INGREDIENT

    Active ingredient

    White Petrolatum USP (100 %)

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  • PURPOSE

    Purpose

    Skin Protectant

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  • INDICATIONS & USAGE

    Uses

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

    • Helps relieve cracked or chapped lips and skin.
    • Helps to protect from the drying effects of wind and cold weather.
    • Helps reduce the appearance of fine dry lines.
    • May be used daily all over your body, face and hands.
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  • WARNINGS

    Warnings

    For External Use Only.

    Keep out of reach of children.

    If swallowed get medical help or contact a poison control center immediately.

    When using this product

    Avoid contact with eyes.

    Do not use on

    • serious burns
    • deep or puncture wounds
    • animal bites

    See a doctor if condition lasts for 7 days.

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

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  • INACTIVE INGREDIENT

    Inactive ingredients

    None

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    100% PURE PETROLEUM JELLY
    For all your moisturizing needs
    Net Wt. 4 oz. (113g) 4 onzas

    PRINCIPAL DISPLAY PANEL
100% PURE PETROLEUM JELLY
Net Wt. 8 fl. oz. (250g) 8 onzas

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  • INGREDIENTS AND APPEARANCE
    PURE PETROLEUM 
    white petroleum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52920-121
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 1 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52920-121-01 225 g in 1 JAR
    2 NDC:52920-121-16 45 g in 1 JAR
    3 NDC:52920-121-17 100 g in 1 JAR
    4 NDC:52920-121-18 113 g in 1 JAR
    5 NDC:52920-121-19 170 g in 1 JAR
    6 NDC:52920-121-20 198 g in 1 JAR
    7 NDC:52920-121-21 283 g in 1 JAR
    8 NDC:52920-121-22 368 g in 1 JAR
    9 NDC:52920-121-23 450 g in 1 JAR
    10 NDC:52920-121-24 500 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 03/10/2010
    Labeler - Singhfam Corporation (019499958)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    Name Address ID/FEI Business Operations
    Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52920-121)
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