Walgreens Calamine Skin Protectant: Package Insert and Label Information

WALGREENS CALAMINE SKIN PROTECTANT- ferric oxide red and zinc oxide lotion
Walgreen Company

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 Facts

Active Ingredients

Calamine 8%

Zinc oxide 8%

Purpose

Skin protectant

Use

For the temporary relief of pain and itching associated with minor skin irritations.

Dries the weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask a doctor if condition 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 immediately.

Directions

  • shake well before using
  • apply with cotton as needed

Other information

Preserve in tight containers, and avoid exposure to excessive heat.

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Distributed by: Walgreen Co.,

200 Wilmot Rd.,

Deerfield, IL 60015-4616

Quality Guaranteed

100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

www.walgreens.com

Front Panel Display Walgreens Calamine Topical Suspension U.S.P. Skin Protectant 177ml (0363-4360-10)

NDC 0363-4360-10
Walgreens
Calamine
Topical Suspension U.S.P.
Skin Protectant
Poison Ivy, Oak,
Sumac Dry Lotion
SAFETY SEALED: DO NOT USE IF INNER SEAL IS BROKEN OR MISSING6 FL OZ (177 ml)

Calamine
(click image for full-size original)
WALGREENS CALAMINE SKIN PROTECTANT ferric oxide red, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4360
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 8 mL in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 8 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENTONITE
CALCIUM HYDROXIDE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-4360-10 177 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/05/2011
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
Humco Holding Group, Inc. 825672884 manufacture

Revised: 10/2011 Walgreen Company

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