Label: CHIGG AWAY- benzocaine lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-9105-94 - Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 19, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only. Keep away from eyes or other mucous membranes. Not for prolonged use. For use on intact skin only. Do not use on children younger than 2 yrs.
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Directions: As an anti-itch.
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Adults and children 2 yrs. of age and over. Apply topically and rub well as needed.
- Children under 2 yrs. of age: Do not use
As an insect (chigger) repellent: Apply around feet, ankles, waist and to skin under all areas of tight clothing and around all openings in outer clothing. Reapply after heavy perspiration.
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Adults and children 2 yrs. of age and over. Apply topically and rub well as needed.
- Other Information
- Inactive Ingredient
- CVS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHIGG AWAY
benzocaine lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) SULFUR (UNII: 70FD1KFU70) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9105-94 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 analysis(0395-9105) , manufacture(0395-9105) , pack(0395-9105) , label(0395-9105)