Label: BUDPAK MEDICATED ANTI ITCH- camphor (synthetic) and menthol cream
- NDC Code(s): 27293-027-01, 27293-027-28
- Packager: Budpak Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
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- ACTIVE INGREDIENT
External anti-infective and anesthetic
Anti itch pain reliefClose
- INDICATIONS & USAGE
For the temporary relief of pain and itching associated with:
- minor skin irritation
- allergic itches
- minor burns
- insect bites
- poison ivy
- poison oak
- poison sumac
For external use onlyClose
- DO NOT USE
Do not use on children under 2 years of age.
- avoid contact with eyes
- do not apply to open wound or damaged skin.
- STOP USE
Stop use and ask a doctor
- if condition worsens
- symptoms persist for 7 days or clear up and occur again within a few days.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
For children under 2 years of age: consult a physician.
- SPL UNCLASSIFIED SECTION
- Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF)
- Lot No. & Exp. Date: see crimp of tube.
- INACTIVE INGREDIENT
Purified Water, Petrolatum, Cetearyl Alcohol, Glycerin, Mineral Oil, Steareth-21, Glyceryl Stearate, Steareth-2, Alcohol, Carbomer, Triethanolamine, Methylparaben, Propylparaben, Aloe barbadensis leaf juice, Vitamin E.Close
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
Budpak Medicated Anti-Itch Cream
NET WT 1 OZ (28 g)Close
- INGREDIENTS AND APPEARANCE
BUDPAK MEDICATED ANTI ITCH
camphor and menthol cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:27293-027 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.01 g in 1 g MENTHOL (MENTHOL) MENTHOL 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength WATER PETROLATUM CETOSTEARYL ALCOHOL GLYCERIN MINERAL OIL STEARETH-21 GLYCERYL MONOSTEARATE STEARETH-2 ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) TROLAMINE METHYLPARABEN PROPYLPARABEN ALOE VERA LEAF .ALPHA.-TOCOPHEROL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27293-027-01 1 in 1 BOX 1 NDC:27293-027-28 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/17/2012 Labeler - Budpak Inc. (183224849) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(27293-027)