CALAMINE PLUS  - ferric oxide red, pramoxine hydrochloride and zinc oxide aerosol, spray 
Wal-Mart Stores, Inc.

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.

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Active Ingredients

Drug Facts

Active ingredients

Calamine 8%

Pramoxine HCL 1%

Purpose

Purpose

Skin protectant

External analgesic

Keep out of reach of children

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

Uses

Uses temporarily relieves pain and itching associated with:

  • insect bites
  • rashes
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

Warnings

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Flammable

Flammable: Do not use while smoking, or near heat or flame. Do not puncture or incinerate.Contents under pressure. Do not store at temperatures above 120 degrees F.

When using this product

When using this product

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days

Directions

Directions

  • shake well before using
  • adults and children 2 years of age and older
  • cleanse the skin with soap and water
  • let dry before use
  • apply as needed to the affected area, not more than 3 to 4 times a day

Other information

Other information

store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive ingredients

Inactive ingredients

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate


Questions?

Questions ? Call 1-866-964-0939

Product label

equate

Compare to Caldryl Active Ingredient

No-Rub

Calamine Plus Spray

Calamine 8%, Pramaxine HCL 1%

External Analgesic, Skin Protectant

Relieves pain and itching from:

  • Poison Ivy, Oak and Sumac
  • Sprays on pink
6 FL OZ (177mL)
Net WT 4.1 OZ (116 g)

SHAKE WELL BEFORE USING

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 Wal-Mart Stores, Inc. Made in USA

*This product is not manufactured or distributed by Johnson and Johnson Consumer Companies Inc. owner of the registered trademark Caladryl
Calamine Plus Label

CALAMINE PLUS  
ferric oxide red, pramoxine hydrochloride, zinc oxide aerosol, spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED0.345 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE2.72 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE24.16 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CAMPHOR (SYNTHETIC) 
HYDRATED SILICA 
ISOBUTANE 
OLEYL ALCOHOL 
SORBITAN TRIOLEATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-030-01177 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2013
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Premier Brands of America, Inc. (063849780)
Establishment
NameAddressID/FEIBusiness Operations
Premier Brands of America, Inc.063849780repack(49035-030), label(49035-030)

Revised: 3/2013
 
Wal-Mart Stores, Inc.