FDA Label for Welly Calm Balm
View Indications, Usage & Precautions
Welly Calm Balm Product Label
The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Diphenhydramine hydrochloride 2%
Zinc Acetate 0.1%
Purpose
Topical analgesic
Skin protectant
Uses
For temporary relief from pain and itching associated with :
- insect bites
- minor burns
- sunburn
- minor skin irritations
- rashes due to poison ivy, poison oak, and poison sumac
- ivy
- oak
- sumac
Dries the oozing and weeping of poison
Warnings
For external use only
Do not use
- on large areas of the body
- with any other product containing diphenhydramine , even one taken by the mouth.
- on chicken pox
- on measles
- conditions worsen or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur agian within a few days
Ask a Doctor before use
When using this product avoid contact with eyes.
Stop use and ask a doctor if
Keep This And All Drugs Out Of The Reach Of Children.
If swallowed get medical help or contact a Poison Control Center immediately.
Directions
- do not use more than directed
- adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
- children under 2 years of age , consult a doctor
- Store at controlled room temperature 20°-25°C (68° - 77°F)
- Close the cap tightly after use
Other Information
Inactive Ingredients
Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate 1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water
Principal Display Panel .57 Oz Tube
Welly First aid NDC 72663-069-59
Extra Strength ANTI -ITCH cream
2% Diphenhydramine HCL topical analgesic
0.1% Zinc Acetate skin protectant
NET WT 0.57 oz (16g)
Principal Display Panel -Can
Welly Calm Balm First aid NDC 72663-069-59
Extra Strength ANTI -ITCH cream
2% Diphenhydramine HCL topical analgesic
0.1% Zinc Acetate skin protectant
NET WT 0.57 oz (16g)
2- Tubes 1.14 oz ( 32g)
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